[Federal Register: March 28, 2006 (Volume 71, Number 59)]
[Notices]
[Page 15422-15467]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr28mr06-74]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 1998N-0046]
Annual Comprehensive List of Guidance Documents at the Food and
Drug Administration
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA) is publishing its
annual comprehensive list of all guidance documents currently in use at
the agency. This list is being published under FDA's good guidance
practices (GGPs) regulations. It is intended to inform the public of
the existence and availability of all of our current guidance
documents. It also provides information on guidance documents that have
been added or withdrawn in the past year.
DATES: We welcome general comments on this list and on agency guidance
documents at any time.
ADDRESSES: Submit written comments to the Division of Dockets
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane,
rm. 1061, Rockville, MD 20852. Submit electronic comments to http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/dockets/ecomments.
For information on a specific guidance
or to obtain a hard copy of any of the guidances currently in use,
contact the appropriate Center listed in the SUPPLEMENTARY INFORMATION
section of this document.
FOR FURTHER INFORMATION CONTACT: Regarding GGPs: Lisa Helmanis, Office
of Policy (HF-26), Food and Drug Administration, 5600 Fishers Lane,
Rockville, MD 20857, 301-827-3480.
SUPPLEMENTARY INFORMATION:
I. Background
FDA's GGPs were published in the Federal Register of September 19,
2000 (65 FR 56468), and became effective October 19, 2000. GGPs (Sec.
10.115 (21 CFR 10.115)) are intended to ensure involvement of the
public in the development of guidance documents, and to enhance
understanding of the availability, nature, and legal effect of such
guidance. In Sec. 10.115(n)(2), FDA stated that it intended to publish
an annual comprehensive list of guidance documents. The list in this
document updates a comprehensive list that published January 5, 2005
(70 FR 824).
This year FDA has adopted a new format for its annual comprehensive
guidance list. This new format is intended to increase the timeliness
of the annual comprehensive list. For information on a specific
guidance or to obtain a hard copy, please refer to the heading of each
Center's section (sections II through VIII of this document). The list
of guidance documents that have been withdrawn is for those guidances
that have been withdrawn from January 5, 2005, to January 5, 2006. The
list of current guidance documents is a printout of FDA's Web site as
of January 31, 2006 or February 1, 2006. You are encouraged to use
FDA's Web site as the most up-to-date source for all current guidance
documents in use by the agency, as the Web site is updated on a daily
basis.
In accordance with the agency's general policy on guidances, you
may comment on this list and on any FDA guidance document at any time.
We have organized the documents by the issuing Center or Office
within FDA. The dates in the list refer to the date we issued the
guidances or, where applicable, the last date we revised a document.
Because each issuing Center or Office maintains its own database, there
are slight variations in the way in which they provide the information
in this document.
II. Center for Biologics Evaluation and Research (CBER)
For information on a specific guidance document or to obtain a hard
copy, contact: Office of Communication, Training, and Manufacturers
Assistance, Center for Biologics Evaluation and Research, Food and Drug
Administration, 1401 Rockville Pike, Rockville, MD 20852-1448, 1-800-
835-4709 or 301-827-1800, http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/cber/guidelines.htm.
[[Page 15423]]
The following is a list of CBER guidance documents that have been
withdrawn from January 5, 2005, to January 5, 2006.
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Date of Date of
Title of Document Issuance Withdrawal
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Draft Guideline for the Validation of 9/28/1993 3/9/2005
Blood Establishment Computer Systems
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Draft Guidance for Reviewers: Premarket 8/3/2001 6/28/2005
Notification Submissions for Automated
Testing Instruments Used in Blood
Establishments
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Guidance for Industry: Discontinuation 5/6/2005 6/30/2005
of Donor Referral Related to Recent
Fever with Headache as a Symptom of
West Nile Virus Infection
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The following is a copy of the list of current CBER guidance
documents obtained from the FDA Web site on March 14, 2006.
CBER Guidance Documents (obtained from the FDA Web site on March 14, 2006)
2006
----------------------------------------------------------------------------------------------------------------
Draft Guidance for Industry: Clinical Data Needed to Support the Licensure of Pandemic Influenza Vaccines--3/2/
2006
Draft Guidance for Industry: Clinical Data Needed to Support the Licensure of Trivalent Inactivated Influenza
Vaccines--3/2/2006
FDA Initiative Helps Expedite Development of Seasonal and Pandemic Flu Vaccines--3/2/2006
Guidance for Industry: Reports on the Status of Postmarketing Study Commitments--Implementation of Section 130
of the Food and Drug Administration Modernization Act of 1997--2/15/2006
Guidance for Industry: Considerations for Developmental Toxicity Studies for Preventive and Therapeutic Vaccines
for Infectious Disease Indications--2/13/2006
Draft Guidance for Industry: Patient-Reported Outcome Measures: Use in Medical Product Development to Support
Labeling Claims--2/2/2006
Guidance for Industry: Adverse Reactions Section of Labeling for Human Prescription Drug and Biological
Products--Content and Format--1/18/2006
Guidance for Industry: Clinical Studies Section of Labeling for Human Prescription Drug and Biological Products--
Content and Format--1/18/2006
Draft Guidance for Industry: Warnings and Precautions, Contraindications, and Boxed Warning Sections of Labeling
for Human Prescription Drug and Biological Products--Content and Format--1/18/2006
Draft Guidance for Industry: Labeling for Human Prescription Drug and Biological Products--Implementing the New
Content and Format Requirements--1/18/2006
Draft Guidance for Industry: INDs--Approaches to Complying with CGMP During Phase 1--1/12/2006
Guidance for Industry: Formal Dispute Resolution: Scientific and Technical Issues Related to Pharmaceutical
CGMP--1/11/2006
Guidance for Industry: Fast Track Drug Development Programs--Designation, Development, and Application Review--1/
11/2006
Appendix 2
Appendix 3--CDER MAPP 6020.3, CBER SOPP 8405
Appendix 4
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2005
----------------------------------------------------------------------------------------------------------------
Draft Guidance for Clinical Trial Sponsors: Establishment and Operation of Clinical Trial Data Monitoring
Committees--12/30/2005
FEDERAL REGISTER: Agency Information Collection Activities; Submission for Office of Management and Budget
Review; Comment Request; Draft Guidance for Clinical Trial Sponsors: Establishment and Operation of Clinical
Trial Data Monitoring Committees--12/30/3005
Draft Guidance for Industry: Safety, Efficacy, and Pharmacokinetic Studies to Support Marketing of Immune
Globulin Intravenous (Human) as Replacement Therapy for Primary Humoral Immunodeficiency--11/30/2005
Guidance for Industry: MedWatch Form FDA 3500A: Mandatory Reporting of Adverse Reactions Related to Human Cells,
Tissues, and Cellular and Tissue-Based Products (HCT/Ps)--11/30/2005
Draft Guidance for Industry: Recommendations for Implementing a Collection Program for Source Plasma Containing
Disease-Associated and Other Immunoglobulin (IgG) Antibodies--10/19/2005
International Conference on Harmonisation (ICH); Guidance for Industry: E14 Clinical Evaluation of QT/QTc
Interval Prolongation and Proarrhythmic Potential for Non-Antiarrhythmic Drugs--10/19/2005
International Conference on Harmonisation (ICH); Guidance for Industry: S7B Nonclinical Evaluation of the
Potential for Delayed Ventricular Repolarization (QT Interval Prolongation) by Human Pharmaceuticals--10/19/
2005
Guidance for Industry: Providing Regulatory Submissions in Electronic Format--Human Pharmaceutical Product
Applications and Related Submissions Using the eCTD Specifications--10/18/2005
International Conference on Harmonisation (ICH); Guidance for Industry: Granularity Document Annex to M4:
Organization of the CTD--10/18/2005
Draft Guidance for Industry and FDA Staff: Compliance with Section 301 of the Medical Device User Fee and
Modernization Act of 2002, as amended--Prominent and Conspicuous Mark of Manufacturers on Single-Use Devices--
10/7/2005
Draft Guidance for Industry and FDA Staff: Compliance with Section 301 of the Medical Device User Fee and
Modernization Act of 2002--Identification of Manufacturer of Medical Devices--6/19/2003
Draft Guidance for Industry and FDA Review Staff: Collection of Platelets by Automated Methods--9/30/2005
International Conference on Harmonisation (ICH); Guidance for Industry: E2B(R) Clinical Safety Data Management:
Data Elements for Transmission of Individual Case Safety Reports--9/30/2005
Draft Guidance for Industry: Using Electronic Means to Distribute Certain Product Information--9/29/2005
Guidance for Industry: Collection of Race and Ethnicity Data in Clinical Trials--9/19/2005
Guidance for Industry, FDA Staff, and FDA-Accredited Third Parties: Requests for Inspection by an Accredited
Person under the Inspection by Accredited Persons Program Authorized by Section 201 of the Medical Device User
Fee and Modernization Act of 2002--9/15/2005
Draft Guidance for Industry: How to Comply with the Pediatric Research Equity Act--9/7/2005
International Conference on Harmonisation (ICH); Draft Guideline: M5 Data Elements and Standards for Drug
Dictionaries--9/2/2005
[[Page 15424]]
Draft Guidance for Industry: Gene Therapy Clinical Trials--Observing Participants for Delayed Adverse Events--8/
23/2005
International Conference on Harmonisation (ICH); Draft Consensus Guideline: Q9 Quality Risk Management--8/5/2005
Draft Guidance for Industry: Nucleic Acid Testing (NAT) for Human Immunodeficiency Virus Type 1 (HIV-1) and
Hepatitis C Virus (HCV): Testing, Product Disposition, and Donor Deferral and Reentry--7/19/2005
Draft Guidance: Emergency Use Authorization of Medical Products--7/5/2005
FEDERAL REGISTER: Guidance for Industry: Discontinuation of Donor Deferral Related to Recent Fever with Headache
as a Symptom of West Nile Virus Infection; Withdrawal of Guidance--6/30/2005
International Conference on Harmonisation (ICH); Guidance for Industry: Q5E Comparability of Biotechnological/
Biological Products Subject to Changes in Their Manufacturing Process--6/29/2005
FEDERAL REGISTER: Draft Guidance for Food and Drug Administration Reviewers: Premarket Notification Submissions
for Automated Testing Instruments Used in Blood Establishments; Withdrawal of Guidance--6/28/2005
Guidance for Industry: Assessing Donor Suitability and Blood and Blood Product Safety in Cases of Known or
Suspected West Nile Virus Infection--6/23/2005
Draft Guidance for Industry: Bar Code Label Requirements--Questions and Answers--6/7/2005
Guidance for Industry: Nonclinical Studies for the Safety Evaluation of Pharmaceutical Excipients--5/18/2005
Guidance for Industry and FDA Staff: Guidance for the Content of Premarket Submissions for Software Contained in
Medical Devices--5/12/2005
Draft Guidance for Industry: Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in
Preventive Vaccine Clinical Trials--4/29/2005
Reviewer Guidance: Evaluating the Risks of Drug Exposure in Human Pregnancies--4/27/2005
Guidance for Industry and FDA Staff: Application User Fees for Combination Products--4/20/2005
Guidance for Industry: Providing Regulatory Submissions in Electronic Format--Content of Labeling--4/20/2005
Guidance for Industry and FDA Staff: Submission and Resolution of Formal Disputes Regarding the Timeliness of
Premarket Review of a Combination Product--4/11/2005
Draft Guidance for Industry: Clinical Trial Endpoints for the Approval of Cancer Drugs and Biologics--4/1/2005
International Conference on Harmonisation (ICH); Guidance for Industry: E2E Pharmacovigilance Planning--3/31/
2005
Guidance for Review Staff and Industry: Good Review Management Principles for PDUFA Products--3/30/2005
Guidance for Industry: Premarketing Risk Assessment--3/25/2005
Guidance for Industry: Development and Use of Risk Minimization Action Plans--3/25/2005
Guidance for Industry: Good Pharmacovigilance Practices and Pharmacoepidemiologic Assessment--3/25/2005
Draft Guidance for Industry: Using a Centralized IRB Review Process in Multicenter Clinical Trials--3/25/2005
Guidance for Industry: Pharmacogenomic Data Submissions--3/22/2005
Attachment to Guidance on Pharmacogenomic Data Submissions--3/22/2005
International Conference on Harmonisation (ICH) Guidance for Industry: M2: eCTD Specification; Questions &
Answers and Change Requests--3/11/2005
Companion Document: Current Q&As and Change Requests--3/11/2005--Updated--7/18/2005--Updated--1/6/2006
International Conference on Harmonisation (ICH) Guidance for Industry: M2 eCTD: Electronic Common Technical
Document Specification--4/1/2003
International Conference on Harmonisation (ICH) Guidance for Industry: E2B(M): Data Elements for Transmission of
Individual Case Safety Reports: Questions and Answers (Revision 2)--3/9/2005
FEDERAL REGISTER: Draft Guideline for the Validation of Blood Establishment Computer Systems; Withdrawal of
Guidance--3/9/2005
Draft Guidance for Industry and FDA Staff: Class II Special Controls Guidance Document: Automated Blood Cell
Separator Device Operating by Centrifugal or Filtration Separation Principle--3/9/2005
Draft Guidance for Industry: Manufacturing Biological Drug Substances, Intermediates, or Products Using Spore-
Forming Microorganisms--2/23/2005
Draft Guidance for Industry: Considerations for Plasmid DNA Vaccines for Infectious Disease Indications--2/17/
2005
Points to Consider on Plasmid DNA Vaccines for Preventive Infectious Disease Indications--12/27/1996
FEDERAL REGISTER: Annual Comprehensive List of Guidance Documents at the Food and Drug Administration;
Correction--2/11/2005
FEDERAL REGISTER: Annual Comprehensive List of Guidance Documents at the Food and Drug Administration--1/5/
2005
International Conference on Harmonisation (ICH); Draft Guidance on Q8 Pharmaceutical Development--2/8/2005
Draft Guidance for Industry: Clinical Lactation Studies--Study Design, Data Analysis, and Recommendations for
Labeling--2/7/2005
International Conference on Harmonisation (ICH); Draft Guidance on S8 Immunotoxicity Studies for Human
Pharmaceuticals--2/7/2005
Guidance for Industry: Submitting Separate Marketing Applications and Clinical Data for Purposes of Assessing
User Fees--1/3/2005
----------------------------------------------------------------------------------------------------------------
2004
----------------------------------------------------------------------------------------------------------------
International Conference on Harmonisation (ICH); Guidance for Industry: M-4: CTD--Efficacy: Questions and
Answers (Revision 3)--12/22/2004
International Conference on Harmonisation (ICH); Guidance for Industry: M4: The CTD--General: Questions and
Answers (Revision 3)--12/22/2004
Guidance for Industry and FDA Staff: Use of Symbols on Labels and in Labeling of In Vitro Diagnostic Devices
Intended for Professional Use--11/30/2004
Guidance for Industry: Continuous Marketing Applications: Pilot 2--Scientific Feedback and Interactions During
Development of Fast Track Products Under the Prescription Drug User Fee Act of 1992; Notice of extension of
application deadline--11/19/2004
Guidance for Industry: Continuous Marketing Applications: Pilot 2--Scientific Feedback and Interactions During
Development of Fast Track Products Under PDUFA--10/6/2003
Guidance for Industry and FDA Staff: Resolution of Disputes Concerning Payment or Refund of Medical Device User
Fees Under MDUFMA--11/17/2004
Guidance for Industry: Recommendations for Obtaining a Labeling Claim for Communicable Disease Donor Screening
Tests Using Cadaveric Blood Specimens from Donors of Human Cells, Tissues, and Cellular and Tissue-Based
Products (HCT/Ps)--11/12/2004
Draft Guidance for FDA Review Staff and Sponsors: Content and Review of Chemistry, Manufacturing, and Control
(CMC) Information for Human Gene Therapy Investigational New Drug Applications (INDs)--11/8/2004
Draft Guidance for Industry: Criteria for Safety and Efficacy Evaluation of Oxygen Therapeutics as Red Blood
Cell Substitutes--10/28/2004
[[Page 15425]]
Guidance for Industry: Use of Nucleic Acid Tests on Pooled and Individual Samples from Donors of Whole Blood and
Blood Components (including Source Plasma and Source Leukocytes) to Adequately and Appropriately Reduce the
Risk of Transmission of HIV-1 and HCV--10/21/2004
Guidance for Industry, FDA Staff, and Third Parties: Implementation of the Inspection by Accredited Persons
Program Under The Medical Device User Fee and Modernization Act of 2002; Accreditation Criteria--10/1/2004
Guidance for Industry: FDA Review of Vaccine Labeling Requirements for Warnings, Use Instructions, and
Precautionary Information--10/1/2004
Guidance for Industry: Sterile Drug Products Produced by Aseptic Processing--Current Good Manufacturing
Practice--9/29/2004
Draft Guidance for Industry: Quality Systems Approach to Pharmaceutical Current Good Manufacturing Practice
Regulations--9/29/2004
Draft Guidance for Industry and FDA: Current Good Manufacturing Practice for Combination Products--9/29/2004
Draft Guidance for Industry: Computerized Systems Used in Clinical Trials 9/29/2004
Guidance for Industry: Computerized Systems Used in Clinical Trials--5/10/1999
FEDERAL REGISTER--Annual Guidance Agenda--9/23/2004
Guidance for Industry and Clinical Investigators: The Use of Clinical Holds Following Clinical Investigator
Misconduct--9/2/2004
Guidance on Research Involving Coded Private Information or Biological Specimens--8/30/2004
Guidance for Industry and FDA: FY 2005 MDUFMA Small Business Qualification Worksheet and Certification--8/20/
2004
Guidance for Industry: Independent Consultants for Biotechnology Clinical Trial Protocols--8/18/2004
Guidance for Industry: Available Therapy--7/21/2004
Guidance for Industry: FDA Export Certificates (Corrected to update the Medical Devices contact phone number 4/
27/2005)--7/12/2004
International Conference on Harmonisation (ICH); Guidance for Industry: Q1F Stability Data Package for
Registration Applications in Climatic Zones III and IV--7/2/2004
Guidance for Industry: Developing Medical Imaging Drug and Biological Products--6/17/2004
Part 1: Conducting Safety Assessments
Part 2: Clinical Indications
Part 3: Design, Analysis, and Interpretation of Clinical Studies
International Conference on Harmonisation (ICH); Guidance for Industry: M4: The CTD--Quality: Questions and
Answers/Location Issues--6/8/2004
International Conference on Harmonisation (ICH); Guidance for Industry: Q1E Evaluation of Stability Data--6/7/
2004
International Conference on Harmonisation (ICH); Guidance for Industry: E5--Ethnic Factors in the Acceptability
of Foreign Clinical Data--Questions and Answers--6/3/2004
Guidance for Industry and FDA Staff: User Fees and Refunds for Premarket Notification Submissions (510(k)s)--5/
28/2004
Guidance for Industry and FDA Staff: FDA and Industry Actions on Premarket Notification (510(k)) Submissions:
Effect on FDA Review Clock and Performance Assessment--5/20/2004
Draft Guidance for Industry: Eligibility Determination for Donors of Human Cells, Tissues, and Cellular and
Tissue-Based Products (HCT/Ps)--5/20/2004
Questions and Answers for Roll-Out of Donor Eligibility Final Rule and Draft Guidance
Draft Guidance for Industry: Acceptable Full-Length Donor History Questionnaire and Accompanying Materials for
Use in Screening Human Donors of Blood and Blood Components--4/23/2004
Draft Guidance for Industry: Vaccinia Virus--Developing Drugs to Mitigate Complications from Smallpox
Vaccination--3/8/2004
International Conference on Harmonisation (ICH); Guidance for Industry: Addendum to E2C Clinical Safety Data
Management: Periodic Safety Update Reports for Marketed Drugs--2/4/2004
International Conference on Harmonisation (ICH); Guidance for Industry: E2C Clinical Safety Data Management:
Periodic Safety Update Reports for Marketed Drugs--11/1996
Draft Guidance for Industry and FDA: Consumer-Directed Broadcast Advertising of Restricted Devices--2/4/2004
Draft Guidance for Industry: Brief Summary: Disclosing Risk Information in Consumer-Directed Print
Advertisements--2/4/2004
Example of Fictional Highlights of Prescribing Information (Based on Proposed Physician Labeling Rule)--2/4/
2004
Example of Fictional Highlights of Prescribing Information (Based on Proposed Physician Labeling Rule)
Translated in Consumer-Friendly Language and Formatted for Use in Consumer-Directed Advertisement--2/4/2004
Draft Guidance for Industry: ``Help-Seeking'' and Other Disease Awareness Communications by or on Behalf of Drug
and Device Firms--2/4/2004
Draft Guidance for Industry: Information Program on Clinical Trials for Serious or Life-Threatening Diseases and
Conditions (Revision 1)--1/26/2004
Guidance for Industry: Information Program on Clinical Trials for Serious or Life-Threatening Diseases and
Conditions--3/18/2002
Guidance for Industry: IND Exemptions for Studies of Lawfully Marketed Drug or Biological Products for the
Treatment of Cancer (Revision 1)--1/16/2004
Draft Guidance for Industry: Drug Substance--Chemistry, Manufacturing, and Controls Information--1/6/2004
----------------------------------------------------------------------------------------------------------------
2003
----------------------------------------------------------------------------------------------------------------
Guidance for Industry and FDA Staff: Class II Special Controls Guidance Document: Human Dura Mater--12/17/2003
Guidance for Industry: An Acceptable Circular of Information for the Use of Human Blood and Blood Components--12/
09/2003
Guidance for Industry and FDA Staff: Expedited Review of Premarket Submissions for Devices--11/21/2003
Guidance for Industry and FDA Staff: User Fees and Refunds for Premarket Approval Applications--11/21/2003
Guidance for Industry and FDA Staff: Bundling Multiple Devices or Multiple Indications in a Single Submission--
11/21/2003
Guidance for Industry and FDA: Assessing User Fees: PMA Supplement Definitions, Modular PMA Fees, BLA and
Efficacy Supplement Definitions, Bundling Multiple Devices in a Single Application, and Fees for Combination
Products--3/12/2003
International Conference on Harmonisation (ICH); Guidance for Industry: Q1A(R2) Stability Testing of New Drug
Substances and Products--11/20/2003
International Conference on Harmonisation (ICH); Guidance for Industry: Q3B(R) Impurities in New Drug Products--
11/13/2003
International Conference on Harmonisation (ICH); Guidance for Industry: Q3C--Tables and List--11/12/2003
Guidance for Industry: Q3C Impurities: Residual Solvents--12/24/1997
Guidance for Industry: Product Recalls, Including Removals and Corrections--10/31/2003
Guidance for Industry and FDA Staff: Premarket Approval Application Modular Review--10/31/2003
[[Page 15426]]
Guidance for Industry and FDA Staff: Class II Special Controls Guidance Document: Serological Reagents for the
Laboratory Diagnosis of West Nile Virus--10/30/2003
Draft Guidance for Industry: Providing Regulatory Submissions in Electronic Format--General Considerations--10/
22/2003
Guidance for Industry: Providing Regulatory Submissions in Electronic Format--General Considerations--1/28/
1999
Guidance for Industry and FDA Staff: FDA and Industry Actions on Premarket Approval Applications (PMAs): Effect
on FDA Review Clock and Performance Assessment--10/8/2003
Guidance for Industry: Continuous Marketing Applications: Pilot 1--Reviewable Units for Fast Track Products
Under PDUFA--10/6/2003
Guidance for Industry: Notifying FDA of Fatalities Related to Blood Collection or Transfusion--9/22/2003
Guidance for Industry: Revised Recommendations for the Assessment of Donor Suitability and Blood Product Safety
in Cases of Suspected Severe Acute Respiratory Syndrome (SARS) or Exposure to SARS--9/16/2003
Guidance for Industry: Recommendations for the Assessment of Donor Suitability and Blood Product Safety in
Cases of Suspected Severe Acute Respiratory Syndrome (SARS) or Exposure to SARS--4/17/2003
Question and Answer on FDA Guidance Entitled ``Recommendations for the Assessment of Donor Suitability and
Blood and Blood Product Safety in Cases of Suspected and Probable Severe Acute Respiratory Syndrome (SARS)
or Exposure to SARS''--Since Publication of this guidance, CDC issued a health alert for travelers arriving
from Toronto Canada, and updated their case definition. As discussed in the guidance under section II.B.3.,
Updated Information on Case Definitions in Areas Affected by SARS, the FDA indicated that you should
consult with the CDC website and phone number for updates. Phone (888) 246-2675.
Updated Interim U.S. Case Definition of Severe Acute Respiratory Syndrome (SARS). http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.cdc.gov/ncidod/
sars/casedefinition.htm.
ICH Draft Guidance: E2D Post-Approval Safety Data Management: Definitions and Standards for Expedited Reporting--
9/12/2003
Draft Guidance for Industry: Comparability Protocols--Protein Drug Products and Biological Products--Chemistry,
Manufacturing, and Controls Information--9/3/2003
Guidance for Industry: Part 11, Electronic Records; Electronic Signatures--Scope and Application--9/3/2003
Draft Guidance for Industry: Providing Regulatory Submissions in Electronic Format--Annual Reports for New Drug
Applications and Abbreviated New Drug Applications--8/27/2003
Draft Guidance for Reviewers: Instructions and Template for Chemistry, Manufacturing, and Control (CMC)
Reviewers of Human Somatic Cell Therapy Investigational New Drug Applications (INDs)--8/15/2003
Guidance for Industry and FDA: FY 2004 MDUFMA Small Business Qualification Worksheet and Certification--8/1/2003
Draft Guidance for Industry and FDA Staff: Premarket Assessment of Pediatric Medical Devices--7/24/2003
Guidance for Industry: Streamlining the Donor Interview Process: Recommendations for Self-Administered
Questionnaires--7/3/2003
Guidance for Industry and FDA Staff: Medical Device User Fee and Modernization Act of 2002, Validation Data in
Premarket Notification Submissions (510(k)s) for Reprocessed Single-Use Medical Devices--7/3/2003
Draft Guidance for Industry: Revised Recommendations for Donor and Product Management Based on Screening Tests
for Syphilis--6/25/2003
Draft Guidance for Industry: Providing Regulatory Submissions in Electronic Format--Postmarketing Periodic
Adverse Drug Experience Reports--6/23/2003
Guidance for FDA Staff: The Leveraging Handbook, An Agency Resource for Effective Collaborations--6/19/2003
Guidance for Industry: Pharmacokinetics in Patients With Impaired Hepatic Function: Study Design, Data Analysis,
and Impact on Dosing and Labeling--5/30/2003
Guidance for Industry: Exposure-Response Relationships--Study Design, Data Analysis, and Regulatory
Applications--5/5/2003
Guidance for Industry and FDA Staff: Premarket Approval Application Filing Review--5/1/2003
FEDERAL REGISTER--Annual Guidance Agenda--4/4/2003
Guidance for Industry: Source Animal, Product, Preclinical, and Clinical Issues Concerning the Use of
Xenotransplantation Products in Humans--4/3/2003
International Conference on Harmonisation (ICH) Guidance for Industry: M2 eCTD: Electronic Common Technical
Document Specification--4/1/2003
International Conference on Harmonisation (ICH) Guidance for Industry: M2: eCTD Specification; Questions &
Answers and Change Requests--3/11/2005
Companion Document: Current Q&As and Change Requests--3/11/2005--Updated--7/18/2005--Updated--1/6/2006
Guidance for Industry and FDA: FY 2003 MDUFMA Small Business Qualification Worksheet and Certification--3/12/
2003
Draft Guidance for Industry; Comparability Protocols--Chemistry, Manufacturing, and Controls Information--2/20/
2003
International Conference on Harmonisation (ICH); Guidance for Industry: Q3A Impurities in New Drug Substances--2/
11/2003
Guidance for Industry and FDA Staff: Quality System Information for Certain Premarket Application Reviews--2/3/
2003
International Conference on Harmonisation (ICH); Guidance for Industry: M4: The CTD--Safety: Questions and
Answers--2/3/2003
Draft Guidance for Industry: Drug Product: Chemistry, Manufacturing, and Controls Information--1/28/2003
International Conference on Harmonisation (ICH); Guidance for Industry; Q1D Bracketing and Matrixing Designs for
Stability Testing of New Drug Substances and Products--1/15/2003
Draft Guidance for Industry and Reviewers on Estimating the Safe Starting Dose in Clinical Trials for
Therapeutics in Adult Healthy Volunteers--1/15/2003
Guidance for Industry: Recommendations for Deferral of Donors and Quarantine and Retrieval of Blood and Blood
Products in Recent Recipients of Smallpox Vaccine (Vaccinia Virus) and Certain Contacts of Smallpox
VaccineRecipients--12/30/2002--(Corrected 2/4/2003)
Questions and Answers on FDA Guidance Entitled ``Recommendations for Deferral of Donors and Quarantine and
Retrieval of Blood and Blood Products in Recent Recipients of Smallpox Vaccine (Vaccinia Virus) and Certain
Contacts of Smallpox Vaccine Recipients''
----------------------------------------------------------------------------------------------------------------
2002
----------------------------------------------------------------------------------------------------------------
The Least Burdensome Provisions of the FDA Modernization Act of 1997: Concept and Principles; Final Guidance for
FDA and Industry--10/3/2002
Guidance for Industry: Establishing Pregnancy Exposure Registries--9/20/2002--
Draft Guidance for Industry: Drugs, Biologics, and Medical Devices Derived from Bioengineered Plants for Use in
Humans and Animals--9/6/2002
Draft Guidance for Industry: Preventive Measures to Reduce the Possible Risk of Transmission of Creutzfeldt-
Jakob Disease (CJD) and Variant Creutzfeldt-Jakob Disease (vCJD) by Human Cells, Tissues, and Cellular and
Tissue-Based Products (HCT/Ps)--6/14/2002
Guidance for Industry: Special Protocol Assessment--5/16/2002
Guidance for Industry: Container Closure Systems for Packaging Human Drugs and Biologics; Questions and Answers--
5/13/2002
[[Page 15427]]
Guidance for Industry: Container Closure Systems for Packaging Human Drugs and Biologics; Chemistry,
Manufacturing, and Controls Documentation--7/7/1999
Draft Guidelines for Ensuring the Quality of Information Disseminated to the Public--5/2/2002--HHS Guideline
Draft Guidance for Industry: A Modified Lot-Release Specification for Hepatitis B Surface Antigen (HBsAg) Assays
Used to Test Blood, Blood Components and Source Plasma Donations--4/10/2002
Guidance for Industry: Providing Regulatory Submissions to CBER in Electronic Format--Investigational New Drug
Applications (INDs)--3/26/2002
Electronic IND Demo
Guidance for Industry: Validation of Procedures for Processing of Human Tissues Intended for Transplantation--3/
8/2002
Draft Guidance for Industry: Precautionary Measures to Reduce the Possible Risk of Transmission of Zoonoses by
Blood and Blood Products from Xenotransplantation Product Recipients and Their Intimate Contacts--2/1/2002
Draft Guidance for Industry: Precautionary Measures to Reduce the Possible Risk of Transmission of Zoonoses by
Blood and Blood Products from Xenotransplantation Product Recipients and Their Contacts--12/23/1999
Guidance for Industry: General Principles of Software Validation; Final Guidance for Industry and FDA Staff--1/
11/2002
Guidance for Industry: Revised Preventive Measures to Reduce the Possible Risk of Transmission of Creutzfeldt-
Jakob Disease (CJD) and Variant Creutzfeldt-Jakob Disease (vCJD) by Blood and Blood Products--1/9/2002
Questions and Answers on ''Guidance for Industry: Revised Preventive Measures to Reduce the Possible Risk of
Transmission of Creutzfeldt-Jakob Disease (CJD) and Variant Creutzfeldt-Jakob Disease (vCJD) by Blood and
Blood Products''
----------------------------------------------------------------------------------------------------------------
2001
----------------------------------------------------------------------------------------------------------------
Guidance for Industry Information Request and Discipline Review Letters Under the Prescription Drug User Fee
Act--11/21/2001
Draft Guidance for Clinical Trial Sponsors On the Establishment and Operation of Clinical Trial Data Monitoring
Committees--11/15/2001
Guidance for Industry--Recommendations for Assessment of Donor Suitability and Blood and Blood Product Safety in
Cases of Possible Exposure to Anthrax--10/17/2001
International Conference on Harmonisation (ICH); Guidance on M4 Common Technical Document--10/16/2001--
M4: Organization of the CTD
M4E: The CTD--Efficacy
M4Q: The CTD--Quality
M4S: The CTD--Safety
M4S: The CTD--Safety Appendices
Guidance for Industry: Content and Format of Geriatric Labeling--10/5/2001
Guidance for Industry: Cancer Drug and Biological Products--Clinical Data in Marketing Applications--10/5/2001
International Conference on Harmonisation (ICH) Guidance; Q7A Good Manufacturing Practice Guide for Active
Pharmaceutical Ingredients--9/25/2001
Draft Guidance for Industry: Submitting Marketing Applications According to the ICH-CTD Format--General
Considerations--9/5/2001
Draft Guidance for Industry: Premarket Notifications [510(k)s] for In Vitro HIV Drug Resistance Genotype Assays:
Special Controls--8/28/2001
Draft Guidance for Industry: Submitting Type V Drug Master Files to the Center for Biologics Evaluation and
Research--8/22/2001
Guidance for Industry: Variances for Blood Collection from Individuals with Hereditary Hemochromatosis--8/22/
2001
Draft Guidance for Industry: Biological Product Deviation Reporting for Blood and Plasma Establishments--8/10/
2001
Draft Guidance for Industry: Biological Product Deviation Reporting for Licensed Manufacturers of Biological
Products Other than Blood and Blood Components--8/10/2001
Guidance for Industry: Changes to an Approved Application: Biological Products: Human Blood and Blood Components
Intended for Transfusion or for Further Manufacture--8/7/2001
Guidance for FDA Reviewers: Premarket Notification Submissions for Blood and Plasma Warmers--7/19/2001
Guidance for FDA Reviewers: Premarket Notification Submissions for Transfer Sets (Excluding Sterile Connecting
Devices)--7/19/2001
Guidance for FDA Reviewers: Premarket Notification Submissions for Empty Containers for the Collection and
Processing of Blood and Blood Components--7/19/2001
ICH Guidance for Industry: S7A Safety Pharmacology Studies for Human Pharmaceuticals--7/12/2001
Guidance for Industry: Revised Recommendations Regarding Invalidation of Test Results of Licensed and 510(k)
Cleared Bloodborne Pathogen Assays Used to Test Donors--7/11/2001
Guidance for Industry: CBER Pilot Licensing Program for Immunization of Source Plasma Donors Using Immunogen Red
Blood Cells Obtained From An Outside Supplier--7/11/2001
Guidance for Industry: IND Meetings for Human Drugs and Biologics; Chemistry, Manufacturing and Controls
Information--5/25/2001
Draft Guidance for Industry: Forms for Registration of Producers of Drugs and Listing of Drugs in Commercial
Distribution--5/14/2001
ICH Guidance for Industry: E 10 Choice of Control Group and Related Issues in Clinical Trials--5/11/2001
Draft Guidance for Industry: Providing Regulatory Submissions in Electronic Format--Postmarketing Expedited
Safety Reports--5/3/2001
Guidance for Industry: Monoclonal Antibodies Used as Reagents in Drug Manufacturing--3/29/2001
Guidance for Industry: Financial Disclosure by Clinical Investigators--3/28/2001
Guidance for Industry: Acceptance of Foreign Clinical Studies--3/13/2001
Draft Guidance for Industry: Postmarketing Safety Reporting for Human Drug and Biological Products Including
Vaccines--3/12/2001
Draft Guidance for Industry: Disclosing Information Provided to Advisory Committees in Connection with Open
Advisory Committee Meetings Related to the Testing or Approval of Biologic Products and Convened by the Center
for Biologics Evaluation and Research--2/15/2001
Guidance for Industry: Recommendations for Collecting Red Blood Cells by Automated Apheresis Methods--Technical
Correction February 2001--2/13/2001
Draft Guidance for Industry: Providing Regulatory Submissions in Electronic Format--Prescription Drug
Advertising and Promotional Labeling--1/31/2001
Draft Guidance for Industry: Pre-Storage Leukocyte Reduction of Whole Blood and Blood Components Intended for
Transfusion--1/23/2001
PHS Guideline on Infectious Disease Issues in Xenotransplantation--1/19/2001
----------------------------------------------------------------------------------------------------------------
2000
----------------------------------------------------------------------------------------------------------------
International Conference on Harmonisation; Guidance on Q6A Specifications: Test Procedures and Acceptance
Criteria for New Drug Substances and New Drug Products: Chemical Substances--12/29/2000
[[Page 15428]]
International Conference on Harmonisation (ICH) Guidance for Industry: E11 Clinical Investigation of Medicinal
Products in the Pediatric Population--12/15/2000
Draft Guidance for Industry: Recommendations for Complying With the Pediatric Rule (21 CFR 314.55(a) and
601.27(a))--12/4/2000
Guidance for Industry: Use of Sterile Connecting Devices in Blood Bank Practices--11/22/2000
Guidance for Reviewers: Potency Limits for Standardized Dust Mite and Grass Allergen Vaccines: A Revised
Protocol--11/20/2000
Guidance for Industry: Testing Limits in Stability Protocols for Standardized Grass Pollen Extracts--11/20/2000
Guidance for Industry: Submitting and Reviewing Complete Responses to Clinical Holds--10/26/2000
Guidance for Industry: Supplemental Guidance on Testing for Replication Competent Retrovirus in Retroviral
Vector Based Gene Therapy Products and During Follow-up of Patients in Clinical Trials Using Retroviral
Vectors--10/18/2000
Guidance for Industry: Q & A Content and Format of INDs for Phase 1 Studies of Drugs, Including Well-
Characterized, Therapeutic, Biotechnology-Derived Products--10/3/2000
Guidance for Industry: Content and Format of Investigational New Drug Applications (INDs) for Phase 1 Studies
of Drugs, Including Well-Characterized, Therapeutic, Biotechnology-derived Products--11/1995
Draft Guidance for Industry: Analytical Procedures and Methods Validation--Chemistry, Manufacturing, and
Controls Documentation--8/30/2000
Guidance for Industry and FDA Staff: Guidance on Amended Procedures for Advisory Panel Meetings--7/22/2000
Draft Guidance for Industry: Chronic Cutaneous Ulcer and Burn Wounds--Developing Products for Treatment--6/28/
2000
Guidance for Industry: Availability of Licensed Donor Screening Tests Labeled for Use with Cadaveric Blood
Specimens--6/23/2000
Draft Guidance for Industry: Pediatric Oncology Studies In Response to a Written Request--6/21/2000
Draft Guidance for Industry: Recommendations for Donor Questioning Regarding Possible Exposure to Malaria--6/8/
2000
Guidance for Industry: Recognition and Use of a Standard for the Uniform Labeling of Blood and Blood Components--
6/6/2000
Guidance for Industry: United States Industry Consensus Standard for the Uniform labeling of Blood and Blood
Components Using ISBT 128--11/1999
Guidance for Industry: Gamma Irradiation of Blood and Blood Components: A Pilot Program for Licensing--3/15/2000
Guidance for Industry: Formal Meetings With Sponsors and Applicants for PDUFA Products--3/7/2000
Guidance for Industry: Formal Dispute Resolution: Appeals Above the Division Level--3/7/2000
International Conference on Harmonsation of Technical Requirements for Registration of Pharmaceuticals for Human
Use--2/10/2000
----------------------------------------------------------------------------------------------------------------
1999
----------------------------------------------------------------------------------------------------------------
Guidance for Industry: In the Manufacture and Clinical Evaluation of In Vitro Tests to Detect Nucleic Acid
Sequences of Human Immunodeficiency Viruses Types 1 and 2--12/14/1999
Guidance for Industry: In Vivo Drug Metabolism / Drug Interaction Studies--Study Design, Data Analysis and
Recommendations for Dosing and Labeling--11/24/1999
REVISED Guidance for Industry: Providing Regulatory Submissions to the Center for Biologics Evaluation and
Research (CBER) in Electronic Format--Biologics Marketing Applications [Biologics License Application (BLA),
Product License Application (PLA) / Establishment License Application (ELA) and New Drug Application (NDA)]--11/
12/1999, REVISED 11/22/1999
CBER Computer Assisted License Application (CALA) Questionnaire
Guidance for Industry: Qualifying for Pediatric Exclusivity Under Section 505A of the Federal Food, Drug and
Cosmetic Act--10/8/1999
Guidance for Industry: Submission of Abbreviated Reports and Synopses in Support of Marketing Applications--9/13/
1999
Guidance for Industry: Possible Dioxin/PCB Contamination of Drug and Biological Products--8/27/1999
ICH Guidance on Specifications: Test Procedures and Acceptance Criteria for Biotechnological/Biological
Products--8/18/1999
Guidance for Industry: Consumer-Directed Broadcast Advertisements--8/6/1999
Draft Guidance for Industry: Cooperative Manufacturing Arrangements for Licensed Biologics--8/3/1999
Draft Guidance for Industry: Interpreting Sameness of Monoclonal Antibody Products Under the Orphan Drug
Regulations--7/24/1999
Draft Guidance for Industry: Clinical Development Programs for Drugs, Devices, and Biological Products Intended
for the Treatment of Osteoarthritis (OA)--7/15/1999
ICH Guidance on the Duration of Chronic Toxicity Testing in Animals (Rodent and Nonrodent Toxicity Testing);
Availability--6/25/1999
Draft Guidance for Industry: Current Good Manufacturing Practice for Blood and Blood Components: (1) Quarantine
and Disposition of Prior Collections from Donors with Repeatedly Reactive Screening Tests for Hepatitis C Virus
(HCV); (2) Supplemental Testing, and the Notification of Consignees and Transfusion Recipients of Donor Test
Results for Antibody to HCV (Anti-HCV)--6/17/1999
FEDERAL REGISTER Notice of Availability--6/22/1999
Guidance for Industry: Current Good Manufacturing Practice for Blood and Blood Components: (1) Quarantine and
Disposition of Units from Prior Collections from Donors with Repeatedly Reactive Screening Tests for Antidoby
to Hepatitis C Virus (Anti-HCV); (2) Supplemental Testing, and the Notification of Consignees and Blood
Recipients of Donor Test Results for Anti-HCV--9/23/1998
Guidance for Industry: Efficacy Studies to Support Marketing of Fibrin Sealant Products Manufactured for
Commercial Use--5/20/1999
Draft Guidance for Industry For Platelet Testing and Evaluation of Platelet Substitute Products--5/20/1999
Guidance for Industry For the Submission of Chemistry, Manufacturing and Controls and Establishment Description
Information for Human Blood and Blood Components Intended for Transfusion or for Further Manufacture and For
the Completion of the Form FDA 356h ``Application to Market a New Drug, Biologic or an Antibiotic Drug for
Human Use''--5/10/1999
Guidance for Industry On the Content and Format of Chemistry, Manufacturing and Controls Information and
Establishment Description Information for an Allergenic Extract or Allergen Patch Test--4/23/1999
Guidance for Industry: Public Health Issues Posed by the Use of Nonhuman Primate Xenografts in Humans--4/6/1999
Draft Guidance for Industry: Accelerated Approval Products--Submission of Promotional Materials--3/26/1999
Draft Guidance for Industry: Product Name Placement, Size and Prominence in Advertising and Promotional
Labeling--3/12/1999
Guidance for Industry: Content and Format of Chemistry, Manufacturing and Controls Information and Establishment
Description Information for a Biological In Vitro Diagnostic Product--3/8/1999
Guidance for Industry: For the Submission of Chemistry, Manufacturing and Controls and Establishment Description
Information for Human Plasma-Derived Biological Products, Animal Plasma or Serum-Derived Products--2/17/1999
Guidance for Industry: Clinical Development Programs for Drugs, Devices and Biological Products for the
Treatment of Rheumatoid Arthritis (RA)--2/17/1999
Guidance for Industry: Population Pharmacokinetics--2/10/1999
Guidance for Industry: FDA Approval of New Cancer Treatment Uses for Marketed Drug and Biological Products--2/3/
1999
[[Page 15429]]
Guidance for Industry: Content and Format of Chemistry, Manufacturing and Controls Information and Establishment
Description Information for a Vaccine or Related Product--1/5/1999
----------------------------------------------------------------------------------------------------------------
1998
----------------------------------------------------------------------------------------------------------------
Draft Guidance for Industry: General Considerations for Pediatric Pharmacokinetic Studies for Drugs and
Biological Products--11/30/1998
Guidance for Industry; Advisory Committees: Implementing Section 120 of the Food and Drug Administration
Modernization Act of 1997--10/30/1998
Draft Guidance for Industry: Submitting Debarment Certification Statements--10/2/1998
ICH Guidance on Viral Safety Evaluation of Biotechnology Products Derived From Cell Lines of Human or Animal
Origin--9/24/1998
Guidance for Industry: Current Good Manufacturing Practice for Blood and Blood Components: (1) Quarantine and
Disposition of Units from Prior Collections from Donors with Repeatedly Reactive Screening Tests for Antidoby
to Hepatitis C Virus (Anti-HCV); (2) Supplemental Testing, and the Notification of Consignees and Blood
Recipients of Donor Test Results for Anti-HCV--9/23/1998
ICH Guidance on Quality of Biotechnological/Biological Products: Derivation and Characterization of Cell
Substrates Used for Production of Biotechnological/Biological Products--9/21/1998
ICH Guidance on Statistical Principles for Clinical Trials--9/16/1998
Withdrawal of ``Guidance for Industry: Supplemental Testing and the Notification of Consignees of Donor Test
Results for Antibody to Hepatitis C Virus (Anti-HCV)''--Information Sheet--9/8/1998
Guidance for Industry: Supplemental Testing and the Notification of Consignees of Donor Test Results for
Antibody to Hepatitis C Virus (Anti-HCV)--3/20/1998
Guidance for Industry: How to Complete the Vaccine Adverse Reporting System Form (VAERS-1)--9/8/1998
Guidance for Industry: Environmental Assessment of Human Drug and Biologics Applications--7/27/1998
Guidance for Industry: Implementation of Section 126 of the Food and Drug Administration Modernization Act of
1997--Elimination of Certain Labeling Requirements--7/21/1998
Draft Guidance for Industry: Exports and Imports Under the FDA Export Reform and Enhancement Act of 1996--6/12/
1998
Guidance for Industry: Errors and Accidents Regarding Saline Dilution of Samples Used for Viral Marker Testing--
6/11/1998
ICH Guidance on Ethnic Factors in the Acceptability of Foreign Clinical Data--6/10/1998
Draft Guidance for Industry: Stability Testing of Drug Substances and Drug Products--6/8/1998
Guidance for Industry: Providing Clinical Evidence of Effectiveness for Human Drugs and Biological Products--5/
15/1998
Guidance for Industry: Standards for the Prompt Review of Efficacy Supplements, Including Priority Efficacy
Supplements--5/15/1998
Guidance for Industry: Pharmacokinetics in Patients with Impaired Renal Function--Study Design, Data Analysis
and Impact on Dosing and Labeling--5/15/1998
Guidance for Industry: Classifying Resubmissions in Response to Action Letters--5/14/1998
Draft Guidance for Industry: Instructions for Submitting Electronic Lot Release Protocols to the Center for
Biologics Evaluation and Research--5/13/1998
Draft Guidance for Industry: Manufacturing, Processing or Holding Active Pharmaceutical Ingredients--4/17/1998
Guidance for Industry: Guidance for Human Somatic Cell Therapy and Gene Therapy--3/30/1998
Draft Guidance for Industry: Container and Closure Integrity Testing in Lieu of Sterility Testing as a Component
of the Stability Protocol for Sterile Products--1/28/1998
Guidance for Industry: Year 2000 Date Change for Computer Systems and Software Applications Used in the
Manufacture of Blood Products--1/8/1998
----------------------------------------------------------------------------------------------------------------
1997
----------------------------------------------------------------------------------------------------------------
Draft Guidance for Industry: Promoting Medical Products in a Changing Healthcare Environment; I. Medical Product
Promotion by Healthcare Organizations or Pharmacy Benefits Management Companies (PBMS)--12/1997
Final Guidance on Industry-Supported Scientific and Educational Activities; Notice--12/3/1997
Guidance for FDA and Industry: Direct Final Rule Procedures--11/21/1997
Guidance for Industry: Industry-Supported Scientific and Educational Activities--11/1997
Guidance for Industry--The Sourcing and Processing of Gelatin to Reduce the Potential Risk Posed by Bovine
Spongiform Encephalopathy (BSE) in FDA-Regulated Products for Human Use--10/07/1997
Guidance for Industry--Postmarketing Adverse Experience Reporting for Human Drug and Licensed Biological
Products: Clarification of What to Report--8/27/1997
Guidance for Industry--Donor Screening for Antibodies to HTLV-II--8/15/1997
Guidance for Industry--Screening and Testing of Donors of Human Tissue Intended for Transplantation--7/29/1997
Guidance for Industry--Changes to an Approved Application: Biological Products--7/24/1997
Guidance for Industry--Changes to an Approved Application for Specified Biotechnology and Specified Synthetic
Biological Products--7/24/1997
International Conference on Harmonisation (ICH) Guidance for Industry: Q2B Validation of Analytical Procedures:
Methodology--5/19/1997
International Conference on Harmonisation (ICH) Guidelines for the Photostability Testing of New Drug Substances
and Products--5/16/1997
Guidance for Industry for the Evaluation of Combination Vaccines for Preventable Diseases: Production, Testing
and Clinical Studies--4/10/1997
Proposed Approach to Regulation of Cellular and Tissue-Based Products--2/28/1997
Points to Consider in the Manufacture and Testing of Monoclonal Antibody Products for Human Use--2/28/1997
Guidance For the Submission of Chemistry, Manufacturing and Controls Information and Establishment Description
for Autologous Somatic Cell Therapy Products--1/10/1997
----------------------------------------------------------------------------------------------------------------
1996
----------------------------------------------------------------------------------------------------------------
Guidance for Industry for the Submission of Chemistry, Manufacturing, and Controls Information for a Therapeutic
Recombinant DNA-Derived Product or a Monoclonal Antibody Product for In Vivo Use--8/1996
International Conference on Harmonisation: Final Guidance on Stability Testing of Biotechnological / Biological
Products--7/10/1996
Guidance for Industry--The Content and Format for Pediatric Use Supplements--5/1996
Guidance on Applications for Products Comprised of Living Autologous Cells Manipulated ex vivo and Intended for
Structural Repair or Reconstruction--5/1996
[[Page 15430]]
FDA Guidance Concerning Demonstration of Comparability of Human Biological Products, Including Therapeutic
Biotechnology-Derived Products--4/1996
International Conference on Harmonisation: Final Guideline on the Need for Long-Term Rodent Carcinogenicity
Studies of Pharmaceuticals--3/1996
International Conference on Harmonisation: Final Guideline on Quality of Biotechnical Products: Analysis of the
Expression Construct in Cells Used for the Production of r-DNA Derived Protein Products--2/1996
----------------------------------------------------------------------------------------------------------------
1995 and earlier
----------------------------------------------------------------------------------------------------------------
Draft Reviewers' Guide: Disease Associated Antibody Collection Program--10/1/1995
Draft Reviewers' Guide: Informed Consent for Plasmapheresis / Immunization--10/1/1995
Guideline for Quality Assurance in Blood Establishments--7/11/1995 (NOTE: The text version does not contain
Tables 1-8)
FDA Guidance Document Concerning Use of Pilot Manufacturing Facilities for the Development and Manufacturing of
Biological Products--7/11/1995
Points to Consider in the Manufacture and Testing of Therapeutic Products for Human Use Derived from Transgenic
Animals--1995
Guidance for Industry for the Submission of Chemistry, Manufacturing, and Controls Information for Synthetic
Peptide Substance--11/1/1994
Guidance for Industry for the Submission Documentation for Sterilization Process Validation in Applications for
Human and Veterinary Drug Products--11/1994
Guidance on Alternatives to Lot Release for Licensed Biological Products--7/14/1993
Draft Points to Consider in the Characterization of Cell Lines Used to Produce Biologicals (1993)--7/12/1993
FDA's Policy Statement Concerning Cooperative Manufacturing Arrangements for Licensed Biologics--11/25/1992
Supplement to the Points to Consider in the Production and Testing of New Drugs and Biologics Produced by
Recombinant DNA Technology: Nucleic Acid Characterization and Genetic Stability--4/6/1992
Guideline for the Determination of Residual Moisture in Dried Biological Products--1/1/1990
Guideline for Collection of Blood or Blood Products from Donors with Positive Tests for Infectious Disease
Markers (``High Risk'' Donors)--10/26/1989
Points to Consider in the Collection, Processing, and Testing of Ex-Vivo Activated Mononeuclear Leukocytes for
Administering to Humans--8/22/1989
Draft Points to Consider in the Manufacture and Clinical Evaluation of In Vitro Tests to Detect Antibodies to
the Human Immunodeficiency Virus Type 1--8/8/1989
Revised Guideline for the Collection of Platelets, Pheresis--10/7/1988
Guideline on Validation of the Limulus Amebocyte Lysate Test as an End-Product Endotoxin Test For Human and
Animal Parenteral Drugs, Biological Products and Medical Devices--12/1987
Guideline on General Principles of Process Validation--5/1987
Guideline for the Uniform Labeling of Blood and Blood Components--8/1985
Points to Consider in the Production and Testing of New Drugs and Biologicals Produced by Recombinant DNA
Technology--4/10/1985
Interferon Test Procedures: Points to Consider in the Production and Testing of Interferon Intended for
Investigational Use in Humans--7/28/1983
Guidelines for Immunization of Source Plasma (Human) Donors with Blood Substances--6/1980
----------------------------------------------------------------------------------------------------------------
III. Center for Drug Evaluation and Research (CDER)
For information on a specific guidance document or to obtain a hard
copy, contact: Division of Drug Information, Office of Training and
Communications, Center for Drug Evaluation and Research, Food and Drug
Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-
4573,http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/cder/guidance/index.htm.
The following is a list of CDER guidance documents that have been
withdrawn from January 5, 2005, to January 5, 2006.
------------------------------------------------------------------------
Date of Date of
Title of Document Issuance Withdrawal
------------------------------------------------------------------------
Preclinical Development of Antiviral 11/1/1990 7/6/2005
Drugs
------------------------------------------------------------------------
Conjugated Estrogens, USP: LC-MS Method 3/9/2000 8/12/2005
for Both Qualitative Chemical
Characterization and Documentation of
Qualitative Pharmaceutical Equivalence
------------------------------------------------------------------------
Phenytoin/Phenytoin Sodium Capsules, 3/4/1994 9/6/2005
Tablets and Suspension In Vivo
Bioequivalence and In Vitro
Dissolution Testing
------------------------------------------------------------------------
Organization of an Abbreviated New Drug 3/2/1999 11/18/2005
Application
------------------------------------------------------------------------
Preclinical Development of 9/4/1992 12/29/2005
Immunomodulatory Drugs for Treatment
of HIV Infection and Associated
Disorders
------------------------------------------------------------------------
The following is a copy of a list of current CDER guidance
documents obtained from the FDA Web site as of March 14, 2006.
CDER Guidance Documents (obtained from the FDA Web site on March 14, 2006)
FDA's Good Guidance Practices regulation of September 19, 2000.
Comprehensive List of Guidance Documents (updated 2/28/2006)
Guidance Agenda: Guidances CDER is Planning to Develop During Calendar Year 2006 (03/01/2006)
[[Page 15431]]
New/Revised/Withdrawn List for 2006 (updated 2/28/2006)
New/Revised/Withdrawn List for 2005 (updated 1/4/2006)
----------------------------------------------------------------------------------------------------------------
Advertising
----------------------------------------------------------------------------------------------------------------
Aerosol Steroid Product Safety Information in Prescription Drug Advertising and Promotional Labeling (Issued 12/
1997, Posted 1/12/1998)
Consumer-Directed Broadcast Advertisements (Issued 8/1999, Posted 8/6/1999)
Questions and Answers (Posted 8/6/1999)
Industry-Supported Scientific and Educational Activities (Issued 12/3/1997, Posted 12/4/1997)
----------------------------------------------------------------------------------------------------------------
Advertising Draft
----------------------------------------------------------------------------------------------------------------
Accelerated Approval Products: Submission of Promotional Materials (Posted 3/26/1999)
Brief Summary: Disclosing Risk Information in Consumer-Directed Print Advertisements (Posted 2/4/2004)
Labeling Example
Labeling Example; Consumer-Friendly Version
Consumer-Directed Broadcast Advertising of Restricted Devices (Issued 1/26/2004, Posted 2/4/2004)
``Help-Seeking'' and Other Disease Awareness Communications by or on Behalf of Drug and Device Firms (Issued 1/
26/2004, Posted 2/4/2004)
Product Name Placement, Size, and Prominence in Advertising and Promotional Labeling (Issued 1/1999, Posted 3/12/
1999)
Promoting Medical Products in a Changing Healthcare Environment; I. Medical Product Promotion by Healthcare
Organizations or Pharmacy Management Companies (PBMs) (Issued 12/1997. Posted 1/5/1998)
----------------------------------------------------------------------------------------------------------------
Biopharmaceutics
----------------------------------------------------------------------------------------------------------------
Bioanalytical Method Validation (Issued 5/2001, Posted 5/22/2001)
Bioavailability and Bioequivalence Studies for Orally Administered Drug Products--General Considerations (Issued
3/2003, Posted 3/19/2003)
Cholestyramine Powder in Vitro Bioequivalence (Intermin Guidance)
Clozapine Tablets: In Vivo Bioequivalence and In Vitro Dissolution Testing (Issued 6/17/2005, Posted 6/17/2005)
Corticosteroids, Dermatologic (topical) In Vivo (Issued 6/2/1995, Posted 3/6/1998)
Dissolution Testing of Immediate Release Solid Oral Dosage Forms (Issued 8/1997, Posted 8/25/1997)
Extended Release Oral Dosage Forms: Development, Evaluation, and Application of In Vitro/In Vivo Correlations
(Issued 9/1997, Posted 9/26/1997)
Food-Effect Bioavailability and Fed Bioequivalence Studies (Issued 12/2002, Posted 1/30/2003)
Metaproterenol Sulfate and Albuterol Metered Dose Inhalers In Vitro (Issued 6/27/1989, Posted 3/2/1998)
Potassium Chloride (slow-release tablets and capsules) In Vivo Bioequivalence and In Vitro Dissolution Testing
(Revised 6/6/1994, Posted 6/22/1998)
Statistical Approaches to Establishing Bioequivalence (Issued 2/2001, Posted 2/1/2001)
Waiver of In Vivo Bioavailability and Bioequivalence Studies for Immediate-Release Solid Oral Dosage Forms Based
on a Biopharmaceutics Classification System. (Issued 8/2000, Posted 8/31/2000)
----------------------------------------------------------------------------------------------------------------
Biopharmaceutics (Draft)
----------------------------------------------------------------------------------------------------------------
Bioavailability and Bioequivalence Studies for Nasal Aerosols and Nasal Sprays for Local Action (Posted 4/2/
2003)
Statistical Information from the June 1999 Draft Guidance and Statistical Information for In Vitro
Bioequivalence Data (Posted 4/11/2003)
Conjugated Estrogens, USP-LC-MS Method for Both Qualitative Chemical Characterization and Documentation of
Qualitative Pharmaceutical Equivalence. Withdrawn per August 12, 2005, Federal Register notice.
----------------------------------------------------------------------------------------------------------------
CGMPs (Pharmaceutical CGMPs for the 21st Century)
----------------------------------------------------------------------------------------------------------------
Formal Dispute Resolution: Scientific and Technical Issues Related to Pharmaceutical CGMP (Issued 1/11/2006;
Posted 1/11/2006)
Questions and Answers on Current Good Manufacturing Practices (cGMP) for Drugs (Posted 8/4/2004)
Part 11, Electronic Records; Electronic Signatures--Scope and Application (Posted 9/3/2003)
PAT--A Framework for Innovative Pharmaceutical Development, Manufacturing, and Quality Assurance (posted 9/29/
2004)
Sterile Drug Products Produced by Aseptic Processing--Current Good Manufacturing Practice Posted 9/29/2004
----------------------------------------------------------------------------------------------------------------
CGMPs (Pharmaceutical CGMPs for the 21st Century)--Draft
----------------------------------------------------------------------------------------------------------------
Comparability Protocols--Protein Drug Products and Biological Products--Chemistry, Manufacturing, and Controls
Information (Posted 9/3/2003)
Current Good Manufacturing Practice for Combination Products (Posted 9/29/2004)
INDs--Approaches to Complying with CGMP's for Phase 1 Drugs (Issued 1/12/2006; Posted 1/12/2006)
Powder Blends and Finished Dosage Units--Stratified In-Process Dosage Unit Sampling and Assessment (Issued 11/
2003, Posted 11/6/2003)
Revised Attachments (Issued 11/2003, Posted 11/21/2003)
Quality Systems Approach to Pharmaceutical Current Good Manufacturing Practice Regulations (Posted 9/29/2004)
----------------------------------------------------------------------------------------------------------------
Chemistry
----------------------------------------------------------------------------------------------------------------
BACPAC I: Intermediates in Drug Substance Synthesis; Bulk Actives Postapproval Changes: Chemistry,
Manufacturing, and Controls Documentation (Issued 2/2001, Posted 2/16/2001)
Botanical Drug Products (Issued 6/2004, Posted 6/9/2004)
Changes to an Approved Application for Specified Biotechnology and Specified Synthetic Biological Products
(Issued 7/1997, Posted 7/28/1997)
Changes to an Approved NDA or ANDA (Issued 4/2004, Posted 4/7/2004)
Changes to an Approved NDA or ANDA: Questions and Answers (Issued 1/2001, Posted 1/22/2001)
Changes to an Approved NDA or ANDA; Specifications--Use of Enforcement Discretion for Compendial Changes (Issued
11/19/2004, Posted 11/19/2004)
[[Page 15432]]
Container Closure Systems for Packaging Human Drugs and Biologics (Issued 5/1999, Posted 7/6/1999)
Container Closure Systems for Packaging Human Drugs and Biologics--Questions and Answers (Issued 5/2002,
Posted 5/10/2002)
Demonstration of Comparability of Human Biological Products, Including Therapeutic Biotechnology-derived
Products
Development of New Stereoisomeric Drugs (5/1/1992) (Post Date: 1/3/1996)
Drug Master Files (9/1/1989)
Current DMF Information (e.g. lists, addresses, guidances, etc.)
Drug Master Files for Bulk Antibiotic Drug Substances (Issued 11/1999, Posted 11/26/1999)
Environmental Assessment of Human Drug and Biologics Applications (Issued 7/1998, Posted 7/24/98)
Format and Content of the Chemistry, Manufacturing and Controls Section of an Application* (Issued 2/1987,
Posted 3/2/1998)
Format and Content for the CMC Section of an Annual Report (9/1/1994)
INDs for Phase 2 and Phase 3 Studies Chemistry, Manufacturing, and Controls Information (Posted 5/20/2003)
IND Meetings for Human Drugs and Biologics Chemistry, Manufacturing, and Controls Information (Issued 5/2001,
Posted 6/4/2001)
Monoclonal Antibodies Used as Reagents in Drug Manufacturing (Issued 3/2001, Posted 3/28/2001)
Nasal Spray and Inhalation Solution, Suspension, and Drug Products (Issued 7/2002, Posted 7/3/2002)
NDAs: Impurities in Drug Substances (Issued 2/2000, Posted 2/24/2000)
PAC-ATLS: Postapproval Changes--Analytical Testing Laboratory Sites (Issued 4/28/1998, Posted 4/28/1998)
The Sourcing and Processing of Gelatin to Reduce the Potential Risk Posed by Bovine Spongiform Encephalopathy
(BSE) (12/20/2000)
SUPAC-IR: Immediate-Release Solid Oral Dosage Forms: Scale-Up and Post-Approval Changes: Chemistry,
Manufacturing and Controls, In Vitro Dissolution Testing, and In Vivo Bioequivalence Documentation
SUPAC-IR Questions and Answers about SUPAC-IR Guidance (2/18/1997)
SUPAC-IR/MR: Immediate Release and Modified Release Solid Oral Dosage Forms Manufacturing Equipment Addendum
(Issued 1/1999, Posted 2/25/1999)
SUPAC-MR: Modified Release Solid Oral Dosage Forms Scale-Up and Postapproval Changes: Chemistry, Manufacturing,
and Controls; In Vitro Dissolution Testing and In Vivo Bioequivalence Documentation (Issued 10/6/1997, Posted
10/6/1997)
SUPAC-SS: Nonsterile Semisolid Dosage Forms; Scale-Up and Post-Approval Changes: Chemistry, Manufacturing and
Controls; In Vitro Release Testing and In Vivo Bioequivalence Documentation (Issued 5/1997; Posted 6/16/1997)
Reviewer Guidance, Validation of Chromatographic Methods
Submission Documentation for Sterilization Process Validation in Applications for Human and Veterinary Drug
Products
Submission of Chemistry, Manufacturing, and Controls Information for Synthetic Peptide Substances
Submitting Documentation for the Manufacturing of and Controls for Drug Products* (Issued 2/1987, Posted 3/2/
1998)
Submitting Documentation for the Stability of Human Drugs and Biologics* (Issued 2/1987, Posted 3/2/1998)
Submitting Samples and Analytical Data for Methods Validation
Submitting Supporting Documentation in Drug Applications for the Manufacture of Drug Substances
----------------------------------------------------------------------------------------------------------------
Chemistry (Draft)
----------------------------------------------------------------------------------------------------------------
Analytical Procedures and Methods Validation. (Issued 8/2000, Posted 8/30/2000)
Comparability Protocols--Chemistry, Manufacturing, and Controls Information (Issued 2/2003, Posted 2/20/2003)
Drugs, Biologics, and Medical Devices Derived from Bioengineered Plants for Use in Humans and Animals (Posted 9/
11/2003)
Drug Product: Chemistry, Manufacturing, and Controls Information (Issued 1/2003, Posted 1/28/2003)
Drug Substance: Chemistry, Manufacturing, and Controls Information (Issued 1/2004, Posted 1/6/2004)
Interpreting Sameness of Monoclonal Antibody Products Under the Orphan Drug Regulations (7/24/1999)
Metered Dose Inhaler (MDI) and Dry Powder Inhaler (DPI) Drug Products (Issued 11/13/1998, Posted 11/19/1998,
Posted 9/27/1999)
Liposome Drug Products: Chemistry, Manufacturing, and Controls; Human Pharmacokinetics and Bioavailability; and
Labeling Documentation. (Issued 7/2002, Posted 8/20/2002)
Stability Testing of Drug Substances and Drug Products (Issued 6/5/1998, Posted 6/8/1998)
SUPAC-SS: Nonsterile Semisolid Dosage Forms Manufacturing Equipment Addendum (Issued 12/1998, Posted 1/5/1999)
----------------------------------------------------------------------------------------------------------------
Clinical/Antimicrobial
----------------------------------------------------------------------------------------------------------------
Antiretroviral Drugs Using Plasma HIV RNA Measurements--Clinical Considerations for Accelerated and Traditional
Approval (Issued 10/2002, Posted 10/31/2002)
Clinical Development and Labeling of Anti-Infective Drug Products (Issued 10/1992, Posted 3/2/1998, Revised 2/12/
2001)
Clinical Evaluation of Anti-Infective Drugs (Systemic) (Issued 9/77, Posted 3/2/1998)
----------------------------------------------------------------------------------------------------------------
Clinical/Antimicrobial (Draft)
----------------------------------------------------------------------------------------------------------------
Acute Bacterial Exacerbation of Chronic Bronchitis--Developing Antimicrobial Drugs for Treatment (Issued 7/22/
1998, Posted 7/22/1998)
Acute Bacterial Meningitis--Developing Antimicrobial Drugs for Treatment (Issued 7/22/1998, Posted 7/22/1998)
Acute Bacterial Sinusitis--Developing Antimicrobial Drugs for Treatment (Issued 7/22/1998, Posted 7/22/1998)
Acute or Chronic Bacterial Prostatitis--Developing Antimicrobial Drugs for Treatment (Issued 7/22/1998, Posted 7/
22/1998)
Acute Otitis Media--Developing Antimicrobial Drugs for Treatment (Issued 7/22/1998, Posted 7/22/1998)
Antiviral Drug Development--Conducting Virology Studies and Submitting the Data to the Agency (Issued 5/24/2005,
Posted 5/24/2005)
Bacterial Vaginosis--Developing Antimicrobial Drugs for Treatment (Issued 7/22/1998, Posted 7/22/1998)
Catheter-Related Bloodstream Infections--Developing Antimicrobial Drugs for Treatment (Issued 10/1999, Posted 10/
18/1999)
Community-Acquired Pneumonia--Developing Antimicrobial Drugs for Treatment (Issued 7/22/1998, Posted 7/22/1998)
Complicated Urinary Tract Infections and Pyelonephritis--Developing Antimicrobial Drugs for Treatment (Issued 7/
22/1998, Posted 7/22/1998)
Developing Antimicrobial Drugs--General Considerations for Clinical Trials (Issued 7/22/1998, Posted 7/22/1998)
Empiric Therapy of Febrile Neutropenia--Developing Antimicrobial Drugs for Treatment (Issued 7/22/1998, Posted 7/
22/1998)
Evaluating Clinical Studies Of Antimicrobials In The Division Of Anti-Infective Drug Products (2/18/1997)
Inhalational Anthrax (Post Exposure)--Developing Antimicrobial Drugs (Issued 3/15/2002, Posted 3/15/2002)
Lyme Disease--Developing Antimicrobial Drugs for Treatment (Issued 7/22/1998, Posted 7/22/1998)
Nosocomial Pneumonia--Developing Antimicrobial Drugs for Treatment (Issued 7/22/1998, Posted 7/22/1998)
Role of HIV Drug Resistance Testing in Antiretroviral Drug Development (Issued 11/26/04, Posted 11/26/04)
Secondary Bacterial Infections of Acute Bronchitis--Developing Antimicrobial Drugs for Treatment (Issued 7/22/
1998, Posted 7/22/1998)
[[Page 15433]]
Streptococcal Pharyngitis and Tonsillitis--Developing Antimicrobial Drugs for Treatment (Issued 7/22/1998,
Posted 7/22/1998)
Uncomplicated and Complicated Skin and Skin Structure Infections--Developing Antimicrobial Drugs for Treatment
(Issued 7/22/1998, Posted 7/22/1998)
Uncomplicated Gonorrhea--Developing Antimicrobial Drugs for Treatment (Issued 7/22/1998, Posted 7/22/1998)
Uncomplicated Urinary Tract Infections--Developing Antimicrobial Drugs for Treatment (Issued 7/22/1998, Posted 7/
22/1998)
Vaccinia Virus--Developing Drugs to Mitigate Complications from Smallpox Vaccination (Posted 3/8/2004)
Vulvovaginal Candidiasis--Developing Antimicrobial Drugs for Treatment (Issued 7/22/1998, Posted 7/22/1998)
----------------------------------------------------------------------------------------------------------------
Clinical/Medical
----------------------------------------------------------------------------------------------------------------
Acceptance of Foreign Clinical Studies (Posted 3/12/2001)
Available Therapy (Posted 7/22/2004)
Calcium DTPA and Zinc DTPA Drug Products--Submitting a New Drug Application (Posted 8/13/2004)
Cancer Drug and Biological Products--Clinical Data in Marketing Applications (Posted 10/11/2001)
Clinical Development Programs for Drugs, Devices, and Biological Products for the Treatment of Rheumatoid
Arthritis (RA) (Issued 1/1999, Posted 2/16/1999)
Clinical Development Programs for MDI and DPI Drug Products (Issued 9/19/1994, Posted 3/2/1998)
Clinical Evaluation of Analgesic Drugs (Withdrawn per August 5, 2003, Federal Register Notice)
Clinical Evaluation of Antacid Drugs (Withdrawn per July 20, 2004, Federal Register notice.)
Clinical Evaluation of Anti-Inflammatory and Antirheumatic Drugs (adults and children)
Clinical Evaluation of Antianxiety Drugs (Issued 9/77, Posted 3/2/1998)
Clinical Evaluation of Antidepressant Drugs (Issued 9/77, Posted 3/2/1998)
Clinical Evaluation of Antidiarrheal Drugs (Withdrawn per July 20, 2004, Federal Register notice.)
Clinical Evaluation of Antiepileptic Drugs (adults and children) (Issued 1/1981, Posted 3/2/1998)
Clinical Evaluation of Gastric Secretory Depressant (GSD) Drugs (Withdrawn per July 20, 2004, Federal Register
notice.)
Clinical Evaluation of General Anesthetics (Issued 5/1982, Posted 3/2/1998)
Clinical Evaluation of Hypnotic Drugs (Issued 9/77, Posted 3/2/1998)
Clinical Evaluation of Laxative Drugs (Withdrawn per July 20, 2004, Federal Register notice.)
Clinical Evaluation of Local Anesthetics (Posted 3/2/1998)
Clinical Evaluation of Psychoactive Drugs in Infants and Children (Posted 3/2/1998)
Clinical Evaluation of Radiopharmaceutical Drugs (Withdrawn per July 20, 2004, Federal Register notice.)
Collection of Race and Ethnicity Data in Clinical Trials (Issued 9/16/2005, Posted 9/16/2005)
Content and Format for Pediatric Use Supplements
Content and Format of Investigational New Drug Applications (INDs) for Phase 1 Studies of Drugs, Including Well-
Characterized, Therapeutic, Biotechnology-derived Products
Developing Medical Imaging Drug and Biological Products
Part 1: Conducting Safety Assessments (Issued 6/17/2004, Posted 6/17/2004)
Part 2: Clinical Indications (Issued 6/17/2004, Posted 6/17/2004)
Part 3: Design, Analysis, and Interpretation of Clinical Studies (Issued 6/17/2004, Posted 6/17/2004)
Development and Use of Risk Minimization Action Plans (Issued 3/24/2005, Posted 3/24/2005)
Establishing Pregnancy Exposure Registries (Issued 8/2002, Posted 9/20/2002)
Evaluating the Risks of Drug Exposure in Human Pregnancies (Issued 4/27/2005, Posted 4/27/2005)
FDA Approval of New Cancer Treatment Uses for Marketed Drug and Biological Products (Issued 12/1998, Posted 2/2/
1999, posted 9/14/1999)
FDA Requirements for Approval of Drugs to Treat Non-Small Cell Lung Cancer (Posted 3/2/1998)
FDA Requirements for Approval of Drugs to Treat Superficial Bladder Cancer (Withdrawn per July 20, 2004, Federal
Register notice.)
Format and Content of the Clinical and Statistical Sections of an Application (Issued 7/1988, Posted 5/21/1997)
Format and Content of the Summary for New Drug and Antibiotic Applications* (Issued 2/1987, Posted 3/2/1998)
Formatting, Assembling and Submitting New Drug and Antibiotic Applications* (Issued 2/1987, Posted 3/2/1998)
General Considerations for the Clinical Evaluation of Drugs
General Considerations for the Clinical Evaluation of Drugs in Infants and Children (Issued 9/77, Posted 3/2/
1998)
Good Pharmacovigilance Practices and Pharmacoepidemiologic Assessment (Issued 3/24/2005, Posted 3/24/2005)
Guidance for the Development of Vaginal Contraceptive Drugs (NDA) (Posted 3/2/1998)
Information Sheet Guidance for Sponsors, Clinical Investigators, and IRBs: Waiver of IRB Requirements for Drug
and Biological Product Studies (Issued 1/2006)
IND Exemptions for Studies of Lawfully Marketed Drug or Biological Products for the Treatment of Cancer (Revised
1/15/2004, Posted 1/15/2004)
Internal Radioactive Contamination--Development of Decorporation Agents (Issued 3/1/2006, Posted 3/1/2006)
Integration of Dose-Counting Mechanisms into MDI Drug Products (Issued 3/2003, Posted 3/12/2003)
Levothyroxine Sodium Tablets--In Vivo Pharmacokinetic and Bioavailability Studies and In Vitro Dissolution
Testing (Issued 2/2001, Posted 3/8/2001)
Oncologic Drugs Advisory Committee Discussion on FDA Requirements for Approval of New Drugs for Treatment of
Ovarian Cancer (Posted 3/2/1998)
Oncologic Drugs Advisory Committee Discussion on FDA Requirements or Approval of New Drugs for Treatment of
Colon and Rectal Cancer (Posted 3/2/1998)
Premarketing Risk Assessment (Issued 3/24/2005; Posted 3/24/2005)
Postmarketing Adverse Experience Reporting for Human Drug and Licensed Biological Products: Clarification of
What to Report (Issued 8/27/1997, Posted 8/27/1997)
Postmarketing Reporting of Adverse Drug Experiences (Issued 3/1992, Posted 3/2/1998)
Preparation of Investigational New Drug Products (Human and Animal) (Issued 11/1992, Posted 3/2/1998)
Providing Clinical Evidence of Effectiveness for Human Drug and Biological Products (Issued 5/14/1998, Posted 5/
14/1998)
Prussian Blue Drug Products--Submitting a New Drug Application (Issued 1/2003, Posted 2/4/2003)
Study and Evaluation of Gender Differences in the Clinical Evaluation of Drugs (Issued 7/22/1993, Posted 3/2/
1998)
Study of Drugs Likely to be used in the Elderly (Issued 11/1989, Posted 3/2/1998)
Submission of Abbreviated Reports and Synopses in Support of Marketing Applications (Issued 8/1999, Posted 9/13/
1999)
[[Page 15434]]
The Use of Clinical Holds Following Clinical Investigator Misconduct
----------------------------------------------------------------------------------------------------------------
Clinical/Medical (Draft)
----------------------------------------------------------------------------------------------------------------
Acne Vulgaris: Developing Drugs for Treatment (Issued 9/16/2005, Posted 9/16/2005)
Allergic Rhinitis: Clinical Development Programs for Drug Products (Issued 6/2000, Posted 6/20/2000)
Chronic Cutaneous Ulcer and Burn Wounds--Developing Products for Treatment (Issued 6/2000, Posted 6/27/2000)
Clinical Development Programs for Drugs, Devices, and Biological Products Intended for the Treatment of
Osteoarthritis (Issued 7/07/1999, Posted 7/14/1999)
Clinical Evaluation of Lipid-Altering Agents (Issued 10/1990, Posted 2/18/1998)
Clinical Evaluation of Weight-Control Drugs (9/24/1996, Posted 2/18/1998)
Clinical Trial Endpoints for the Approval of Cancer Drugs and Biologics (Issued 4/1/2005, Posted 4/1/2005)
Development of Parathyroid Hormone for the Prevention and Treatment of Osteoporosis (Issued 5/2000, Posted 6/13/
2000)
Drugs, Biologics, and Medical Devices Derived from Bioengineered Plants for Use in Humans and Animals (Issued 9/
6/2002)
Estrogen and Estrogen/Progestin Drug Products to Treat Vasomotor Symptoms and Vulvar and Vaginal Atrophy
Symptoms--Recommendations for Clinical Evaluation (Issued 1/2003, Posted 1/30/2003)
Evaluation of the Effects of Orally Inhaled and Intranasal Corticosteroids on Growth in Children (Posted 11/6/
2001)
Exercise-Induced Bronchospasm (EIB)--Development of Drugs to Prevent EIB (Issued 2/2002, Posted 2/19/2002)
Exocrine Pancreatic Insufficiency Drug Products--Submitting NDAs (Posted 4/27/2004)
Female Sexual Dysfunction: Clinical Development of Drug Products for Treatment (Issued 5/2000, Posted 5/18/2000)
Gingivitis: Development and Evaluation of Drugs for Treatment or Prevention (Issued June 24, 2005, Posted June
27, 2005)
Guidance for Clinical Trial Sponsors On the Establishment and Operation of Clinical Trial Data Monitoring
Committees (Issued 12/01/2005, Posted 2/07/2006)
Guidance for Institutional Review Boards, Clinical Investigators, and Sponsors: Exception from Informed Consent
Requirements for Emergency Research (3/31/2000)
Inhalation Drug Products Packaged in Semipermeable Container Closure Systems (Issued 7/2002, Posted 7/25/2002)
OTC Treatment of Herpes Labialis with Antiviral Agents (Issued 3/8/2000, Posted 3/8/2000)
Patient-Reported Outcome Measures: Use in Medical Product Development to Support Labeling Claims (Issued 2/2/
2006), Posted 2/2/2006)
Pediatric Oncology Studies In Response to a Written Request (Issued 6/2000, Posted 6/19/2000)
Preclinical and Clinical Evaluation of Agents Used in the Prevention or Treatment of Postmenopausal Osteoporosis
(Issued 4/1994, Posted 2/18/1998)
Recommendations for Complying with the Pediatric Rule (21 CFR 314.55(a) and 601.27(a)) (Posted 12/1/2000)
Systemic Lupus Erythematosus--Developing Drugs for Treatment (Issued 3/28/2005, Posted 3/28/2005)
----------------------------------------------------------------------------------------------------------------
Clinical Pharmacology
----------------------------------------------------------------------------------------------------------------
Drug Metabolism/Drug Interaction Studies in the Drug Development Process: Studies In Vitro (Issued 4/1997,
Posted 4/8/1997)
Exposure-Response Relationships--Study Design, Data Analysis, and Regulatory Applications (Posted 5/5/2003)
Format and Content of the Human Pharmacokinetics and Bioavailability Section of an Application* (Issued 2/1987,
Posted 3/2/1998)
In Vivo Drug Metabolism/Drug Interaction Studies--Study Design, Data Analysis, and Recommendations for Dosing
and Labeling (Issued 11/24/1999, Posted 11/24/1999)
Pharmacokinetics in Patients with Impaired Hepatic Function: Study Design, Data Analysis, and Impact on Dosing
and Labeling (Posted 5/30/2003)
Pharmacokinetics in Patients with Impaired Renal Function (Issued 5/14/1998, Posted 5/14/1998)
Population Pharmacokinetics (Issued 2/1999, Posted 2/10/1999)
----------------------------------------------------------------------------------------------------------------
Clinical Pharmacology (Draft)
----------------------------------------------------------------------------------------------------------------
Clinical Lactation Studies--Study Design, Data Analysis, and Recommendations for Labeling (Issued 2/7/05, Posted
2/8/05)
General Considerations for Pediatric Pharmacokinetic Studies for Drugs and Biological Products (Issued 11/1998,
Posted 11/12/1998)
Pharmacokinetics in Pregnancy--Study Design, Data Analysis, and Impact on Dosing and Labeling (Issued 10/29/
2004, Posted 10/29/2004)
----------------------------------------------------------------------------------------------------------------
Combination Products (Drug/Device/Biologic)
----------------------------------------------------------------------------------------------------------------
Draft and Final guidances can be found on the Office of Combination Products web site.
----------------------------------------------------------------------------------------------------------------
Compliance
----------------------------------------------------------------------------------------------------------------
A Review of FDA's Implementation of the Drug Export Amendments of 1986 (Issued 11/1989, Posted 3/2/1998)
Compressed Medical Gases (Issued 2/1989, Posted 3/10/1997)
Computerized Systems Used in Clinical Trials (Issued 4/1999, Posted 5/11/1999)
General Principles of Process Validation
Good Laboratory Practice Regulations Questions and Answers (Posted 3/2/1998)
Guidance for Hospitals, Nursing Homes, and Other Health Care Facilities--FDA Public Health Advisory (Issued and
Posted 4/5/2001)
Guideline for Validation of Limulus Amebocyte Lysate Test as an End-Product Endotoxin Test for Human and Animal
Parenteral Drugs, Biological Products, and Medical Devices (Posted 3/2/1998)
Expiration Dating and Stability Testing of Solid Oral Dosage Form Drugs Containing Iron (Issued 6/27/1997,
Posted 6/27/1997)
Monitoring of Clinical Investigations (Posted 3/2/1998)
Nuclear Pharmacy Guideline Criteria for Determining When to Register as a Drug Establishment (Posted 3/2/1998)
Pharmacy Compounding--Compliance Policy Guide (Issued 5/2002, Posted 3/12/2004)
Possible Dioxin/PCB Contamination of Drug and Biological Products (Issued 8/23/1999, Posted 8/23/1999)
Prescription Drug Marketing Act--Donation of Prescription Drug Samples to Free Clinics (Issued 3/2006, Posted 3/
13/2006)
Street Drug Alternatives (Issued 3/2000, Posted 3/31/2000)
----------------------------------------------------------------------------------------------------------------
[[Page 15435]]
Compliance (Draft)
----------------------------------------------------------------------------------------------------------------
Bar Code Label Requirements--Questions and Answers. (Issued 6/7/2005, Posted 6/7/2005)
Computerized Systems Used in Clinical Trials (Posted 9/29/2004)
Current Good Manufacturing Practice for Medical Gases (Posted 5/6/2003)
Expiration Dating of Unit-Dose Repackaged Drugs: Compliance Policy Guide (5/27/2005)
Guidance for IRBs, Clinical Investigators, and Sponsors: Exception from Informed Consent Requirements for
Emergency Research (21 CFR 50.24) Draft released for comment 3/30/2000 (5/12/2000)
Investigating Out of Specification (OOS) Test Results for Pharmaceutical Production (Issued 9/30/1998, Posted 9/
30/1998)
Manufacturing, Processing, or Holding Active Pharmaceutical Ingredients (Issued 4/17/1998, Posted 4/17/1998)
Marketed Unapproved Drugs--Compliance Policy Guide (Issued 10/15/2003, Posted 10/17/2003)
PET Drug Products--Current Good Manufacturing Practice (CGMP) (Issued 9/15/2005, Posted 9/15/2005)
----------------------------------------------------------------------------------------------------------------
Drug Safety
----------------------------------------------------------------------------------------------------------------
Conducting a Clinical Safety Review of a New Product Application and Preparing a Report on the Review (Issued 2/
2005, Posted 2/2005)
----------------------------------------------------------------------------------------------------------------
Drug Safety Draft
----------------------------------------------------------------------------------------------------------------
FDA's ``Drug Watch'' for Emerging Drug Safety Information (Issued 5/5/2005; Posted 5/5/2005)
Questions and Answers (Qs & As)
----------------------------------------------------------------------------------------------------------------
Electronic Submissions
----------------------------------------------------------------------------------------------------------------
Part 11, Electronic Records; Electronic Signatures--Scope and Application (Posted 9/3/2003)
Providing Regulatory Submissions in Electronic Format--ANDAs (Issued 6/2002, Posted 6/27/2002)
Providing Regulatory Submissions in Electronic Format--Content of Labeling (Issued 4/20/2005, Posted 4/20/2005)
Providing Regulatory Submissions in Electronic Format--Human Pharmaceutical Product Applications and Related
Submissions Using the eCTD Specifications. To ensure you have the most recent versions of the specifications
referenced in this document, check the appropriate center's guidance Web page. For CBER, this Web site is http:/ /www.fda.gov/cber/esub/esub.htm. For CDER, this Web site is http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/cder/regulatory/ersr/ectd.htm.
r/regulatory/ersr/ectd.htm">http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/cder/regulatory/ersr/ectd.htmder/regulatory/ersr/ectd.htm</A>..
.
Regulatory Submissions in Electronic Format; General Considerations (Issued 1/1999, Posted 1/27/1999)
Regulatory Submissions in Electronic Format; New Drug Applications (Issued 1/1999, Posted 1/27/1999)
SPL Standard for Content of Labeling Technical Qs & As ( Issued 12/2005, Posted 12/8/2005)
Example of an Electronic New Drug Application Submission (Posted 2/17/1999).
----------------------------------------------------------------------------------------------------------------
Electronic Submissions Draft
----------------------------------------------------------------------------------------------------------------
Providing Regulatory Submissions in Electronic Format--Annual Reports for NDAs and ANDAs (Posted 8/27/2003)
Providing Regulatory Submissions in Electronic Format--General Considerations (Issued 10/2003, Posted 10/22/
2003)
Providing Regulatory Submissions in Electronic Format--Postmarketing Expedited Safety Reports (Issued 5/2001,
Posted 5/3/2001)
Providing Regulatory Submissions in Electronic Format--Postmarketing Periodic Adverse Drug Experience Reports
(Posted 6/23/3003)
Providing Regulatory Submissions in Electronic Format--Prescription Drug Advertising and Promotional Labeling
(Issued 1/2001, Posted 1/30/2001)
----------------------------------------------------------------------------------------------------------------
Generics
----------------------------------------------------------------------------------------------------------------
180-Day Exclusivity When Multiple ANDAs Are Submitted on the Same Day (Issued 7/2003, Posted 7/31/2003)
Alternate Source of the Active Pharmaceutical Ingredient in Pending ANDAs (Posted 12/12/2000)
ANDA's: Impurities in Drug Substances (Issued 11/1999, Posted 12/2/1999)
Court Decisions, ANDA Approvals, and 180-Day Exclusivity Under the Hatch-Waxman Amendments to the Federal Food,
Drug, and Cosmetic Act (Posted 3/27/2000)
Handling and Retention of BA and BE Testing Samples (5/25/2004)
Letter announcing that the OGD will now accept the ICH long-term storage conditions as well as the stability
studies conducted in the past. (Posted 3/2/1998)
Letter describing efforts by the CDER and the ORA to clarify the responsibilities of CDER chemistry review
scientists and ORA field investigators in the new and abbreviated drug approval process in order to reduce
duplication or redundancy in the process (Posted 3/2/1998)
Letter on incomplete Abbreviated Applications, Convictions Under GDEA, Multiple Supplements, Annual Reports for
Bulk Antibiotics, Batch Size for Transdermal Drugs, Bioequivalence Protocols, Research, Deviations from OGD
Policy (Posted 3/2/1998)
Letter on the Provision of new information pertaining to new bioequivalence guidelines and refuse-to-file
letters (Posted 3/2/1998)
Letter on the provision of new procedures and policies affecting the generic drug review process (Posted 3/2/
1998)
Letter on the request for cooperation of regulated industry to improve the efficiency and effectiveness of the
generic drug review process, by assuring the completeness and accuracy of required information and data
submissions (Posted 3/2/1998)
Letter on the response to 12/20/1984 letter from the Pharmaceutical Manufacturers Association about the Drug
Price Competition and Patent Term Restoration Act (Posted 3/2/1998)
Letter to all ANDA and AADA applicants about the Generic Drug Enforcement Act of 1992 (GDEA), and the Office of
Generic Drugs intention to refuse-to-file incomplete submissions as required by the new law (Posted 3/2/1998)
Letter to regulated industry notifying interested parties about important detailed information regarding
labeling, scale-up, packaging, minor/major amendment criteria and bioequivalence requirements (Posted 3/2/1998)
Major, Minor, and Telephone Amendments to Abbreviated New Drug Applications (Issued 12/2001, Posted 12/20/2001)
Potassium Chloride Modified-Release Tablets and Capsules: In Vivo Bioequivalence and In Vitro Dissolution
Testing (Issued 10/25/2005; Posted 10/25/2005)
Revising ANDA Labeling Following Revision of the RLD Labeling (Issued 4/26/2000, 4/26/2000)
Variations in Drug Products that May Be Included in a Single ANDA (Issued 12/1998, Posted 1/26/1999)
----------------------------------------------------------------------------------------------------------------
[[Page 15436]]
Generics (Draft)
----------------------------------------------------------------------------------------------------------------
ANDAs: Impurities in Drug Products (Issued 8/26/2005, Posted 8/26/2005)
ANDAs: Impurities in Drug Substances (Issued 1/28/2005, Posted 1/28/2005)
ANDAs: Pharmaceutical Solid Polymorphism (Issued 12/17/2004, Posted 12/17/2004)
Listed Drugs, 30-Month Stays, and Approval of ANDAs and 505(b)(2) Applications Under Hatch-Waxman, as Amended by
the Medicare Prescription Drug, Improvement, and Modernization Act of 2003--Questions and Answers (Issued 10/
2004, Posted 11/3/2004)
----------------------------------------------------------------------------------------------------------------
Good Review Practices (GRPs)
----------------------------------------------------------------------------------------------------------------
Conducting a Clinical Safety Review of a New Product Application and Preparing a Report on the Review (Posted 2/
18/2005)
Pharmacology/Toxicology Review Format (Posted 5/9/2001)
----------------------------------------------------------------------------------------------------------------
Good Review Practices (GRPs) (Draft)
----------------------------------------------------------------------------------------------------------------
Industry Letters
----------------------------------------------------------------------------------------------------------------
Continuation of a series of letters communicating interim and informal generic drug policy and guidance.
Availability of Policy and Procedure Guides, and further operational changes to the generic drug review program
(Posted 3/2/1998)
Fifth of a series of letters providing informal notice about the Act, discussing the statutory mechanism by
which ANDA applicants may make modifications in approved drugs where clinical data is required (Posted 3/2/
1998)
Fourth of a series of letters providing informal notice to all affected parties about policy developments and
interpretations regarding the Act. Three year exclusivity provisions of Title I (Posted 3/2/1998)
Implementation of the Drug Price Competition and Patent Term Restoration Act. Preliminary Guidance (Posted 3/2/
1998)
Implementation Plan USP injection nomenclature (Posted 3/2/1998)
Seventh of a series of letters about the Act providing guidance on the ``130-day exclusivity'' provision of
section 505(j)(4)(B)(iv) of the FD&C (Posted 3/2/1998)
Sixth of a series of informal notice letters about the Act discussing 3- and 5-year exclusivity provisions of
sections 505(c)(3)(D) and 505(j)(4)(D) of the FD&C Act (Posted 3/2/1998)
Supplement to 10/11/1984 letter about policies, procedures and implementation of the Act (Q&A format) (Posted 3/
2/1998)
Third of a series of letters regarding the implementation of the Act (Posted 3/2/1998)
Year 2000 Letter from Dr. Janet Woodcock (10/19/98)
----------------------------------------------------------------------------------------------------------------
International Conference on Harmonisation
----------------------------------------------------------------------------------------------------------------
Safety
S1A The Need for Long-term Rodent Carcinogenicity Studies of Pharmaceuticals
S1B Testing for Carcinogenicity of Pharmaceuticals (Issued 2/28/1998, Posted 3/24/1998)
S1C Dose Selection for Carcinogenicity Studies of Pharmaceuticals
S1C(R) Guidance on Dose Selection for Carcinogenicity Studies of Pharmaceuticals: Addendum on a Limit Dose and
Related Notes (Issued 12/4/1997, Posted 12/11/1997)
S2A Specific Aspects of Regulatory Genotoxicity Tests for Pharmaceuticals
S2B Genotoxicity: A Standard Battery for Genotoxicity Testing of Pharmaceuticals (Issued 11/21/1997, Posted 5/
4/1998)
S3A Toxicokinetics: The Assessment of Systemic Exposure in Toxicity Studies
S3B Pharmacokinetics: Guidance for Repeated Dose Tissue Distribution Studies
S4A Duration of Chronic Toxicity Testing in Animals (Rodent and Nonrodent Toxicity Testing) Posted 6/25/99
S5A Detection of Toxicity to Reproduction for Medicinal Products (Issued 9/1994, Posted 4/23/1997)
S5B Detection of Toxicity to Reproduction for Medicinal Products: Addendum on Toxicity to Male Fertility
S6 Preclinical Safety Evaluation of Biotechnology-Derived Pharmaceuticals (Issued 11/1997, Posted 11/18/1997)
S7A Safety Pharmacology Studies for Human Pharmaceuticals (Issued 7/2001, Posted 7/12/2001)
S7B Nonclinical Evaluation of the Potential for Delayed Ventricular Repolarization (QT Interval Prolongation)
by Human Pharmaceuticals (Issued 10/19/2005, Posted 10/19/2005).
Joint Safety/Efficacy (Multidisciplinary)
M2 eCTD: Electronic Common Technical Document Specification (Posted 4/1/2003)
M2: eCTD Specification Questions and Answers and Change Requests (Posted 3/14/05)
Companion Document: Current Q & As and Change Requests (Issued 1/6/2006; Posted 1/6/2006)
M3 Nonclinical Safety Studies for the Conduct of Human Clinical Trials for Pharmaceuticals (Issued 11/1997,
Posted 11/25/1997)
M4: Common Technical Document for the Registration of Pharmaceuticals for Human Use (Posted 10/15/2001)
M4: Organization of the CTD
M4 Granularity Annex (Issued 10/18/2005, Posted 10/18/2005)
M4: The CTD--General Questions and Answers (Issued 12/04, Posted 12/22/2004)
M4: The CTD--Quality
M4: The CTD--Quality Questions and Answers /Location Issues (Issued 6/2004, Posted 6/8/2004)
M4: The CTD--Efficacy
M4: The CTD--Efficacy Questions and Answers (Issued 12/2004, Posted 12/22/2004)
M4: The CTD--Safety
M4: The CTD--Safety Appendices
M4: The CTD--Safety Questions and Answers (Issued 2/2003, Posted 2/4/2003)
Efficacy
E1A The Extent of Population Exposure to Assess Clinical Safety: For Drugs Intended for Long-term Treatment of
Non-Life-Threatening Conditions
E2A Clinical Safety Data Management: Definitions and Standards for Expedited Reporting
E2B International Conference on Harmonisation; Guidance on Data Elements for Transmission of Individual Case
Safety Reports (Issued 1/15/1998, Posted 1/15/1998)
E2BM Data Elements for Transmission Of Individual Case Safety Reports (Issued 4/2002, Posted 4/4/2002)
[[Page 15437]]
E2B(M) Questions and Answers (Revised 3/09/2005, Posted, 3/16/2005)
E2C Clinical Safety Data Management: Periodic Safety Update Reports for Marketed Drugs (Issued 5/19/1997,
Posted 3/19/1998)
E2C Addendum to ICH E2C Clinical Safety Data Management: Periodic Safety Update Reports for Marketed Drugs
(Posted 2/5/2004)
E2E Pharmacovigilance Planning (Issued 3/31/05; Posted 3/31/05)
E3 Structure and Content of Clinical Study Reports
E4 Dose-Response Information to Support Drug Registration
E5 Ethnic Factors in the Acceptability of Foreign Clinical Data
E5 Questions and Answers (Issue 6/2004, Posted 6/4/2004)
E6 Good Clinical Practice: Consolidated Guideline Spanish Version (Issued 5/9/1997, Posted 3/19/1998)
E7 Studies in Support of Special Populations: Geriatrics
E8 General Considerations for Clinical Trials (Issued 12/1997, Posted 12/17/1997)
E9 Statistical Principles for Clinical Trials (9/1/1998)
E10 Choice of Control Group and Related Issues in Clinical Trials (Issued 5/2001, Posted 5/11/2001)
E11 Clinical Investigation of Medicinal Products in the Pediatric Population (Issued 12/2000, Posted 12/14/
2000)
E14 Clinical Evaluation of QT/QTc Interval Prolongation and Proarrhythmic Potential for Non-Antiarrhythmic
Drugs (Issued 10/19/2005, Posted 10/19/2005)
----------------------------------------------------------------------------------------------------------------
Quality
----------------------------------------------------------------------------------------------------------------
Q1A(R2) Stability Testing of New Drug Substances and Products (Issued 11/2003, Posted 11/20/2003)
Q1B Photostability Testing of New Drug Substances and Products (Issued 11/1996, Reposted 7/7/1998)
Q1C Stability Testing for New Dosage Forms (Issued 5/9/1997, Posted 3/19/1998)
Q1D Bracketing and Matrixing Designs for Stability Testing of New Drug Substances and Products (Issued 1/2003,
Posted 1/15/2003)
Q1E Evaluation of Stability Data (Issued 6/2004, Posted 6/7/2004)
Q1F Stability Data Package for Registration Applications in Climatic Zones III and IV, revision 1 (7/1/2004)
Q2A Text on Validation of Analytical Procedures
Q2B Validation of Analytical Procedures: Methodology (Issued 5/19/1997, Posted 3/19/1997)
Q3A Impurities in New Drug Substances (Issued 2/10/2003, Posted 2/10/2003)
Q3B(R) Impurities in New Drug Products (Issued 11/2003, Posted 11/13/2003)
Q3C Impurities: Residual Solvents or Adobe Acrobat version (Issued 12/24/1997, Posted 12/30/1997)
Q3C Tables and List (Posted 11/12/2003)
Appendix 4, Appendix 5, and Appendix 6 (Appendices were issued with the Q3C draft guidance documents)
Maintenance Procedures for Updating (Posted 2/11/2002)
Q5A Viral Safety Evaluation of Biotechnology Products Derived From Cell Lines of Human or Animal Origin
(Posted 9/1998)
Q5B Quality of Biotechnological Products: Analysis of the Expression Construct in Cells Used for Production of
r-DNA Derived Protein Products
Q5C Quality of Biotechnological Products: Stability Testing of Biotechnological/Biological Products
Q5D Quality of Biotechnological/Biological Products: Derivation and Characterization of Cell Substrates Used
for Production of Biotechnological/Biological Products; Availability (Issued 9/21/1998, Posted 9/21/1998)
Q5E Comparability of Biotechnological/Biological Products Subject to Changes in Their Manufacturing Process
(Issued 6/2005, Posted 6/29/2005)
Q6A International Conference on Harmonisation; Guidance on Q6A Specifications: Test Procedures and Acceptance
Criteria for New Drug Substances and New Drug Products: Chemical Substances. (12/29/2000)
Q6B Specifications: Test Procedures and Acceptance Criteria for Biotechnological/Biological Products (Issued 8/
1999, Posted 12/14/2001)
Q7A Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients (Issued 8/2001, Posted 9/24/
2001]
----------------------------------------------------------------------------------------------------------------
International Conference on Harmonisation (Draft)
----------------------------------------------------------------------------------------------------------------
Efficacy
E2B(R) Clinical Safety Data Management: Data Elements for Transmission of Individual Case Safety Reports
(Issued 9/30/2005, Posted 9/30/2005)
E2D Postapproval Safety Data Management: Definitions and Standards for Expedited Reporting (Posted 9/12/2003)
Principles for Clinical Evaluation of New Antihypertensive Drugs. (Issued 8/2000, Posted 8/8/2000)
Joint Safety/Efficacy (Multidisciplinary) (Draft)
International Conference on Harmonisation; Draft Guidance on M5 Data Elements and Standards for Drug
Dictionaries (Issued 9/2005, Posted 9/2/2005)
Submitting Marketing Applications According to the ICH/CTD Format: General Considerations (Issued 9/2001,
Posted 9/5/2001)
Quality
Q8 Pharmaceutical Development (Issued 2/7/2005, Posted 2/8/2005)
Q9 Quality Risk Management (Issued 8/5/2005, Posted 8/5/2005)
Safety
S8 Immunotoxicity Studies for Human Pharmaceuticals (Issued 2/7/05, Posted 2/8/05)
----------------------------------------------------------------------------------------------------------------
Investigational New Drug Applications
----------------------------------------------------------------------------------------------------------------
Content and Format of Investigational New Drug Applications (INDs) for Phase 1 Studies of Drugs
----------------------------------------------------------------------------------------------------------------
Labeling
----------------------------------------------------------------------------------------------------------------
Adverse Reactions Section of Labeling for Human Prescription Drug and Biological Products--Content and Format
(Issued 1/18/2006; Posted 1/18/2006)
Clinical Studies Section of Labeling for Human Prescription Drug and Biological Products--Content and Format
(Issued 1/18/2006; Posted 1/18/2006)
Content and Format for Geriatric Labeling (Issued 10/2001, Posted 10/4/2001)
----------------------------------------------------------------------------------------------------------------
[[Page 15438]]
Labeling (Draft)
----------------------------------------------------------------------------------------------------------------
Labeling for Combined Oral Contraceptives (Issued 3/2/2004, Posted 3/4/2004)
Labeling for Human Prescription Drug and Biological Products--Implementing the New Content and Format
Requirements (Issued 1/18/2006; Posted 1/18/2006)
Labeling Guidance for OTC Topical Drug Products for the Treatment of Vaginal Yeast Infections (Vulvovaginal
Candidiasis) (Issued 6/1998, Posted 7/20/1998)
Noncontraceptive Estrogen Drug Products for the Treatment of Vasomotor Symptoms and Vulvar and Vaginal Atrophy
Symptoms--Recommended Prescribing Informtion for Health Care Providers and Patient Labeling (Issued 11/15/2005,
Posted 11/15/2005)
Referencing Discontinued Labeling for Listed Drugs in Abbreviated New Drug Applications (Issued 10/2000, Posted
10/25/2000)
Warnings and Precautions, Contraindications, and Boxed Warning Sections of Labeling for Human Prescription Drug
and Biological Products--Content and Format (Issued 1/18/2006; Posted 1/18/2006)
----------------------------------------------------------------------------------------------------------------
Microbiology
----------------------------------------------------------------------------------------------------------------
Format and Content of the Microbiology Section of an Application*
----------------------------------------------------------------------------------------------------------------
Modernization Act of 1997
----------------------------------------------------------------------------------------------------------------
Changes to an Approved NDA or ANDA (Issued 4/2004, Posted 4/7/2004)
Classifying Resubmissions in Response to Action Letters (Issued 5/14/1998, Posted 5/14/1998)
Enforcement Policy During Implementation of Section 503A of the Federal Food, Drug, and Cosmetic Act (Issued 11/
1998, Posted 11/20/1998)
Fast Track Drug Development Programs--Designation, Development, and Application Review (Posted 7/22/2004)
Appendix 2; Appendix 3 consisting of Mapp 6020.3 and SOPP 8405; and Appendix 4 [Appendices are scanned copies,
which will be replaced by final versions] (Issued 11/17/1998, Posted 11/17/1998)
Formal Dispute Resolution: Appeals Above the Division Level (Issued 2/2000, Posted 3/6/2000)
Formal Meetings With Sponsors and Applicants for PDUFA Products (Issued 2/2000, Posted 3/6/2000)
Implementation of Section 120 of the Food and Drug Administration Modernization Act of 1997--Advisory Committees
(Issued 10/1998, Posted 11/02/98)
Implementation of Section 126 of the Food and Drug Administration Modernization Act of 1997--Elimination of
Certain Labeling Requirements (Issued 7/1998, Posted 7/20/98)
Information Program on Clinical Trials for Serious or Life-Threatening Diseases and Conditions (Issued 3/2002,
Posted 3/18/2002)
National Uniformity for Nonpresciption Drugs--Ingredient Listing for OTC Drugs (Issued 4/1998, Posted 5/5/1998)
Providing Clinical Evidence of Effectiveness for Human Drug and Biological Products (Issued 5/14/1998, Posted 5/
14/1998)
Qualifying for Pediatric Exclusivity Under Section 505A of the Federal Food, Drug, and Cosmetic Act (Issued 9/
1999, Posted 10/4/1999)
Frequently Asked Questions on Pediatric Exclusivity (505A), The Pediatric ``Rule,'' and Their Interaction
(Posted 7/27/1999)
Repeal of Section 507 of the Federal Food, Drug and Cosmetic Act (Revised 5/1998, Posted 6/12/1998)
Standards for Prompt Review of Efficacy Supplements (Issued 5/15/1998, Posted 5/15/1998)
Submission of Abbreviated Reports and Synopses in Support of Marketing Applications (Issued 8/1998, Posted 9/15/
98)
Submitting and Reviewing Complete Responses to Clinical Holds (Revised) (Issued 10/2000, Posted 10/25/2000
Women and Minorities Guidance Requirements (Issued 7/20/1998, Posted 11/25/1998)
----------------------------------------------------------------------------------------------------------------
Modernization Act of 1997 (Draft)
----------------------------------------------------------------------------------------------------------------
Information Program on Clinical Trials for Serious or Life-Threatening Diseases and Conditions (Issued 1/2004,
Posted 1/27/2004)
PET Drug Applications--Content and Format for NDAs and ANDAs (Issued 3/7/2000, Posted 3/7/2000)
Sample formats for chemistry, manufacturing, and controls sections
Sample formats for labeling
Sample formats for Form FDA 356h
Sample formats for user fee Form FDA 3397
Reports on the Status of Postmarketing Studies--Implementation of Section 130 of the Food and Drug
Administration Modernization Act of 1997 (Posted 4/4/2001)
----------------------------------------------------------------------------------------------------------------
Over-the-Counter (OTC) Guidances
----------------------------------------------------------------------------------------------------------------
Enforcement Policy on Marketing OTC Combination Products (CPG 7132b.16) (Posted 3/2/1998)
General Guidelines for OTC Combination Products (Posted 3/2/1998)
Labeling OTC Human Drug Products Using a Column Format (Issued 12/2000, Posted 12/18/2000)
Labeling OTC Human Drug Products Updating Labeling in RLDs and ANDAs
Example Drug Facts Labels
Acetaminophen 120 mg in a Suppository Dosage Form
Acetaminophen 325 mg in a Suppository Dosage Form
Acetaminophen 650 mg in a Suppository Dosage Form
Cimetidine 200 mg in a Tablet Dosage Form
Clemastine Fumerate 1.34 mg in a Tablet Dosage Form
Doxylamine Succinate 25 mg Tablet Dosage Form
Ibuprofen 200 mg in a Tablet/Capsule Dosage Form
Loperamide HCl in a Liquid Dosage Form
Loperamide HCl in a Tablet/Caplet Dosage Form
Miconazole Nitrate Vaginal Products
Minoxidil Topical Solution 2% for Men and Women
Minoxidil Topical Solution 5% for Men
Naproxen Sodium 220 mg in a Tablet/Caplet/Gelcap Dosage Form
Pseudoephedrine HCl Extended-Release Tablets 120 mg
[[Page 15439]]
Upgrading Category III Antiperspirants to Category I (43 FR 46728-46731) (Posted 3/2/1998)
----------------------------------------------------------------------------------------------------------------
Over-the-Counter (OTC) Draft
----------------------------------------------------------------------------------------------------------------
Labeling OTC Human Drug Products Questions and Answers (Issued 1/2005, Posted 1/12/05
Labeling OTC Human Drug Products--Submitting Requests for Exemptions and Deferrals (Issued 12/2000, Posted 12/18/
2000)
Labeling OTC Human Drug Products (Small Entity Compliance Guide) (Issued 12/2004, Posted 6/8/2005)
Labeling OTC Human Drug Products Updating Labeling in ANDAs (2/21/2001)
Additional examples 1 (3/19/2001)
Additional examples 2 (3/26/2001)
Additional examples 3 (3/26/2001)
Time and Extent Applications (Issued 2/2004, Posted 2/11/2004)
----------------------------------------------------------------------------------------------------------------
Pharmacology/Toxicology
----------------------------------------------------------------------------------------------------------------
Carcinogenicity Study Protocol Submissions (Issued 5/22/2002)
Content and Format of INDs for Phase 1 Studies of Drugs, Including Well-Characterized, Therapeutic,
Biotechnology-Derived Products
Developing Medical Imaging Drug and Biological Products
Part 1: Conducting Safety Assessments (Issued 6/17/2004, Posted 6/17/2004)
Estimating the Maximum Safe Starting Dose in Initial Clinical Trials for Therapeutics in Adult Healthy
Volunteers (Issued 7/21/2005, Posted 7/21/2005.
Exploratory IND Studies (Issued 1/12/2006; Posted 1/12/2006)
Format and Content of the Nonclinical Pharmacology/Toxicology Section of an Application* (Posted 3/2/1998)
Immunotoxicology Evaluation of Investigational New Drugs (Issued 10/2002, Posted 10/31/2002)
Nonclinical Pharmacology/Toxicology Development of Topical Drugs Intended to Prevent the Transmission of
Sexually Transmitted Diseases (STD) and/or for the Development of Drugs Intended to Act as Vaginal
Contraceptives
Nonclinical Safety Evaluation of Pediatric Drug Products (Issued 2/14/2006, Posted 2/14/2006)
Nonclinical Studies for the Safety Evaluation of Pharmaceutical Excipients (Issued 05/18/2005, Posted 05/18/
2005)
Photosafety Testing (Posted 5/7/2003)
Recommended Approaches to Integration of Genetic Toxicology Study Results (Issued 1/3/2006, Posted 1/3/2006).
Reference Guide for the Nonclinical Toxicity Studies of Antivial Drugs Indicated for the Treatment of N/A Non-
Life Threatening Disease Evaluation of Drug Toxicity Prior to Phase I Clinical Studies (Posted 3/2/1998)
Single Dose Acute Toxicity Testing for Pharmaceuticals
----------------------------------------------------------------------------------------------------------------
Pharmacology/Toxicology Draft
----------------------------------------------------------------------------------------------------------------
Integration of Study Results to Assess Concerns about Human Reproductive and Developmental Toxicities (Issued 11/
2001, Posted 11/9/2001)
Nonclinical Evaluation of Late Radiation Toxicity of Therapeutic Radiopharmaceuticals (Issued 6/17/2005; Posted
6/17/2005)
Nonclinical Safety Evaluation of Drug Combinations (Issued 1/26/05, Posted 1/26/05)
Safety Testing of Drug Metabolites (Issued 6/2005, Posted 6/3/2005)
Statistical Aspects of the Design, Analysis, and Interpretation of Chronic Rodent Carcinogenicity Studies of
Pharmaceuticals (Issued 5/2001, Posted 5/7/2001)
----------------------------------------------------------------------------------------------------------------
Procedural
----------------------------------------------------------------------------------------------------------------
180-Day Generic Drug Exclusivity Under the Hatch-Waxman Amendments to the Federal Food, Drug, and Cosmetic Act
(Issued 6/1998, Posted 6/22/1998)
Continuous Marketing Applications: Pilot 1--Reviewable Units for Fast Track Products Under PDUFA (Posted 10/1/
2003)
Continuous Marketing Applications: Pilot 2--Scientific Feedback and Interactions During Development of Fast
Track Products Under PDUFA (Posted 10/1/2003)
Paperwork Reduction Act Burden Statement (Posted 7/27/2004)
Court Decisions, ANDA Approvals, and 180-Day Exclusivity Under the Hatch-Waxman Amendments to the Federal Food,
Drug, and Cosmetic Act (Posted 3/27/2000)
Disclosure of Materials Provided to Advisory Committees in Connection with Open Advisory Committee Meetings
Convened by the Center for Drug Evaluation and Research Beginning on January 1, 2000 (Issued 11/1999, Posted 11/
29/1999)
Drug Products Containing Ensulizole, Hypromellose, Meradimate, Octinoxate, and Octisalate--Labeling Enforcement
Policy (Posted 6/3/2003)
Enforcement Policy During Implementation of Section 503A of the Federal Food, Drug, and Cosmetic Act (Issued 11/
1998, Posted 11/20/1998)
Fast Track Drug Development Programs--Designation, Development, and Application Review (Posted 1/12/2006)
Appendix 2 ; Appendix 3 consisting of Mapp 6020.3 and SOPP 8405;and Appendix 4 [Appendices are scanned copies,
which will be replaced by final versions 11/18] (Issued 11/17/1998, Posted 11/17/1998)
FDA Export Certicates (Issued 7/2004, Posted 7/13/2004)
Financial Disclosure by Clinical Investigators (3/27/2001)
Formal Dispute Resolution: Appeals Above the Division Level (Issued 2/2000, Posted 3/6/2000)
Formal Meetings With Sponsors and Applicants for PDUFA Products (Issued 2/2000, Posted 3/6/2000)
Good Review Management Principles and Practices for PDUFA Products (Issued 3/2005; Posted 3/30/2005)
Guidance for FDA Staff: The Leveraging Handbook; An Agency Resource for Effective Collaborations (Revised 6/
2003)
Implementation of Section 120 of the Food and Drug Administration Modernization Act of 1997--Advisory Committees
(Issued 10/1998, Posted 11/02/98)
Implementation of Section 126 of the Food and Drug Administration Modernization Act of 1997--Elimination of
Certain Labeling Requirements (Issued 7/1998, Posted 7/20/98)
Independent Consultants for Biotechnology Clinical Trial Protocols (Issued 8/18/2004, Posted 8/192/2004)
Information Program on Clinical Trials for Serious or Life-Threatening Diseases and Conditions (Issued 3/2002,
Posted 3/18/2002)
Information Request and Discipline Review Letters Under the Prescription Drug User Fee Act (Issued 11/2001)
Levothyroxine Sodium Products Enforcement of August 14, 2001 Compliance Date and Submission of New Applications
(Issued 7/2001, Posted 7/12/2001)
[[Page 15440]]
National Uniformity for Nonpresciption Drugs--Ingredient Listing for OTC Drugs (Issued 4/1998, Posted 5/5/1998)
Pharmacogenomic Data Submissions (Issued 3/2005, Posted 3/22/2005)
Examples of Voluntary Submissions or Submissions Required Under 21 CFR 312, 314, or 601 (Issued 3/2005, Posted
3/22/2005)
Potassium Iodide as a Thyroid Blocking Agent in Radiation Emergencies (Issued 12/2001, Posted 12/10/2001)
KI in Radiation Emergencies--Questions and Answers (Issued 12/20/2002, Posted 12/23/2002)
Potassium Iodide Tablets--Shelf Life Extension (Posted 3/8/2004)
Reduction of Civil Money Penalties for Small Entities (Issued 3/20/2001)
Qualifying for Pediatric Exclusivity Under Section 505A of the Federal Food, Drug, and Cosmetic Act (Issued 9/
1999, Posted 10/4/1999)
Refusal to File (Issued 7/12/1993, Posted 11/26/99)
Repeal of Section 507 of the Federal Food, Drug and Cosmetic Act (Revised 5/1998, Posted 6/12/1998)
Reports on the Status of Postmarketing Study Commitments--Implementation of Section 130 of the Food and Drug
Administration Modernization Act of 1997 (Issued 2/15/2006; Posted 2/15/2006)
Special Protocol Assessment (Issued 5/2002, Posted 5/16/2002)
Standards for Prompt Review of Efficacy Supplements (Issued 5/15/1998, Posted 5/15/1998)
Submitting and Reviewing Complete Responses to Clinical Holds (Revised) (Issued 10/2000, Posted 10/25/2000)
----------------------------------------------------------------------------------------------------------------
Procedural Draft
----------------------------------------------------------------------------------------------------------------
Applications Covered by Section 505(b)(2) (Issued 10/1999, Posted 12/7/1999)
Disclosing Information Provided to Advisory Committees in Connection with Open Advisory Committee Meetings
Related to the Testing or Approval of New Drugs and Convened by the Center for Drug Evaluation and Research,
Beginning on January 1, 2000 (Issued 12/1999, Posted 12/22/1999)
Disclosure of Conflicts of Interest for Special Government Employees Participating in FDA Product Specific
Advisory Committees (2/14/2002)
Emergency Use Authorization of Medical Products; Availability (Issued 7/5/2005; Posted 7/5/2005.
Fixed Dose Combination and Co-Packaged Drug Products for Treatment of HIV (5/17/2004)
Forms for Registration of Producers of Drugs and Listing of Drugs in Commercial Distribution (5/14/2001)
How to Comply with the Pediatric Research Equity Act (Posted 9/7/2005)
Independent Consultants for Biotechnology Clinical Trial Protocols (Posted 5/7/2003)
Information Program on Clinical Trials for Serious or Life-Threatening Diseases and Conditions (Issued 1/2004,
Posted 1/27/2004)
PET Drug Applications--Content and Format for NDAs and ANDAs (Issued 3/7/2000, Posted 3/7/2000)
Sample formats for chemistry, manufacturing, and controls sections
Sample formats for labeling
Sample formats for Form FDA 356h
Sample formats for user fee Form FDA 3397
Postmarketing Safety Reporting for Human Drug and Biological Products Including Vaccines (Issued 3/2001, Posted
3/9/2001)
Submitting Debarment Certification Statements (Issued 10/2/98, Posted 10/2/98)
Submitting Marketing Applications According to the ICH/CTD Format: General Considerations (Issued 9/2001, Posted
9/5/2001)
The Use of Clinical Holds Following Clinical Investigator Misconduct (Issued 4/2002, Posted 8/26/2002)
Useful Written Consumer Medication Information (CMI) (Issued 5/25/2005, Posted 5/25/2005)
Using a Centralized IRB Review Process in Multicenter Clinical Trials (Issued 3/25/2005, Posted 3/25/2005)
----------------------------------------------------------------------------------------------------------------
Small Entity Compliance Guides
----------------------------------------------------------------------------------------------------------------
Sterility Requirement for Aqueous-Based Drug Products for Oral Inhalation--Small Entity Compliance Guide (Posted
11/7/2001)
----------------------------------------------------------------------------------------------------------------
Small Entity Compliance Guides (Draft)
----------------------------------------------------------------------------------------------------------------
Labeling OTC Human Drug Products (Small Entity Compliance Guide) (Issued 12/2004, Posted 6/8/2005)
----------------------------------------------------------------------------------------------------------------
User Fees
----------------------------------------------------------------------------------------------------------------
Classifying Resubmissions in Response to Action Letters (Issued 5/14/1998, Posted 5/14/1998)
Fees-Exceed-the-Costs Waivers Under the Prescription Drug User Fee Act (Issued 6/1999, Posted 6/25/99)
Guidance for Industry and FDA Staff: Application User Fees for Combination Products. (Issued 4/2005, Posted 5/3/
2005)
Information Request and Discipline Review Letters Under the Prescription Drug User Fee Act (Issued 11/2001)
Submitting Separate Marketing Applications and Clinical Data for Purposes of Assessing User Fees (Issued 12/30/
2004, Posted 12/30/2004)
----------------------------------------------------------------------------------------------------------------
User Fees (Draft)
----------------------------------------------------------------------------------------------------------------
Attachment G--Draft Interim Guidance Document for Waivers of and Reductions in User Fees (7/16/1993)
User Fee Waivers for FDC and Co-Packaged HIV Drugs for PEPFAR (Issued 4/15/2005, Posted 4/15/2005)
いいいいいいいいいいいいいいいいいいいいいいいいいいいいいいいいいいいいいいいいいいいいいいいいいいいいいいいい
Also see Current Good Manufacturing Practice Regulations
Enforcement of the Postmarketing Adverse Drug Experience Reporting Regulations (Posted 8/11/1997)
----------------------------------------------------------------------------------------------------------------
IV. Center for Devices and Radiological Health (CDRH)
For information on a specific guidance document or to obtain a hard
copy, contact: Division of Small Manufacturers, International and
Consumer Assistance, Center for Devices and Radiological Health, Food
and Drug Administration, 1350 Piccard Dr., Rockville, MD 20850, 1-800-
638-2041 or 301-443-6597, http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/cdrh/guidance.html.
The following is a list of CDRH guidance documents that have been
withdrawn from January 5, 2005, to January 5, 2006.
[[Page 15441]]
------------------------------------------------------------------------
Date of Date of
Title of Document Issuance Withdrawal
------------------------------------------------------------------------
Methods for Conducting Recall June 16, 1978 January 2006
Effectiveness Checks
------------------------------------------------------------------------
Guidance for Clinical Laboratory March 1, 2001 September 7,
Improvement Amendments of 1988 (CLIA) 2005
Criteria for Waiver; Draft Guidance
for Industry and FDA
------------------------------------------------------------------------
Guidance for Industry; In Vitro July 20, 1998 September 22,
Diagnostic C-Reactive Protein 2005
Immunological Test System
------------------------------------------------------------------------
Guidance for Over-the-Counter (OTC) July 22, 2000 September 7,
Ovulation Predictor 510(k)s 2005
------------------------------------------------------------------------
Draft Review Criteria for Nucleic Acid June 14, 1993 December 8,
Amplification Based In Vitro 2005
Diagnostic Devices for Direct
Detection of Infectious Microorganisms
------------------------