[Federal Register: January 5, 2005 (Volume 70, Number 3)]
[Notices]
[Page 824-913]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr05ja05-85]
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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.
-----------------------------------------------------------------------
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been added or withdrawn in the past year.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.
We have provided information in the
tables in the SUPPLEMENTARY INFORMATION section of this document on
where to obtain a single copy of any of the guidance documents listed.
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 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 (Sec. 10.115 (21 CFR
10.115)). 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 October 24, 2001
(66 FR 53836).
The following comprehensive list identifies all guidances that have
been issued and are in use, and all draft guidances that have been
distributed for comment and not for implementation. Any guidances that
have been withdrawn since the last publication of this comprehensive
list are also identified. These withdrawn guidances include some final
and draft guidances that had been withdrawn prior to the date of
publication of this list, and some that are being withdrawn as of this
date. 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.
Please note that although we have stated that the ``Guidance for
Industry on Qualified Health Claims in Labeling of Conventional Foods
and Dietary Supplements'' (December 2002) has been ``replaced'' by
subsequent guidance, the agency has not abandoned the position in the
2002 guidance regarding reasonable consumer standard.
We have organized the documents by the issuing center or office
within FDA, and have identified the pertinent intended users or
regulatory activities. 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
information in the tables in this document.
The following most frequently used Internet sites for agency
guidances are provided for future reference:
Center for Biologics Evaluation and Research (CBER):
http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/cber/guidelines.htm Center for Drug Evaluation and Research (CDER): http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/cder/guidance/index.htm
Center for Devices and Radiological Health (CDRH): http://
http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/cdrh/guidance.html
Center for Food Safety and Applied Nutrition (CFSAN):
http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.cfsan.fda.gov/dms/guidance.html Center for Veterinary Medicine (CVM): http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/cvm/guidance/published.htm
Office of Regulatory Affairs (ORA) and Office of the
[[Page 825]]
/http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/opacom/morechoices/industry/guidance.htm
Guidance Documents Issued by CBER
------------------------------------------------------------------------
How to Obtain a Copy
Intended of the Document
Name of Document Date of User or -----------------------
Issuance Regulatory Mailing Internet
Activity Address Address
------------------------------------------------------------------------
Guidelines for June FDA Office of http://
Immunization of Source 1980 regulated Communica www.fda.g
Plasma (Human) Donors industry tion, ov/cber/
With Blood Substances Training, guideline
and s.htm
Manufactu
rers
Assistanc
e (HFM-
40),
Center
for
Biologics
Evaluatio
n and
Research,
Food and
Drug
Administr
ation,
1401
Rockville
Pike,
Rockville
, MD
20852-144
8, 1-800-
835-4709
or 301-
827-1800
------------------------------------------------------------------------
Collection of Human January Ditto (Do) Do. http://
Leukocytes for Further 28, www.fda.g
Manufacturing (Source 1981 ov/cber/
Leukocytes) memo.htm
------------------------------------------------------------------------
Interferon Test July 28, Do. Do. http://
Procedures: Draft Points 1983 www.fda.g
to Consider (PTC) in the ov/cber/
Production and Testing of guideline
Interferon Intended for s.htm
Investigational Use in
Humans
------------------------------------------------------------------------
Deferral of Blood Donors February Do. Do. http://
Who Have Received the 28, www.fda.g
Drug Accutane 1984 ov/cber/
(isotretinoin/Roche; 13- memo.htm
cis-retinoic acid)
------------------------------------------------------------------------
Equivalent Methods for December Do. Do. Do.
Compatibility Testing 14,
1984
------------------------------------------------------------------------
Plasma Derived From December Do. Do. Do.
Therapeutic Plasma 14,
Exchange 1984
------------------------------------------------------------------------
Draft PTC in the April Do. Do. http://
Production and Testing of 10, www.fda.g
New Drugs and Biologicals 1985 ov/cber/
Produced by Recombinant guideline
DNA Technology s.htm
------------------------------------------------------------------------
Reduction of the Maximum June 2, Do. Do. http://
Platelet Storage Period 1986 www.fda.g
to 5 Days in an Approved ov/cber/
Container memo.htm
------------------------------------------------------------------------
To In Vitro Diagnostic December Do. Do. Do.
Reagent Manufacturers: 6, 1986
Guidance on the Labeling
of Human Blood Derived In
Vitro Diagnostic Devices
in Regard to Labeling for
HTLV-III/LAV Antibody
Testing
------------------------------------------------------------------------
Guideline on General May 1987 Do. Do. http://
Principles of Process www.fda.g
Validation ov/cber/
guideline
s/htm
------------------------------------------------------------------------
Deferral of Donors Who November Do. Do. http://
Have Received Human 25, www.fda.g
Pituitary-Derived Growth 1987 ov/cber/
Hormone memo.htm
------------------------------------------------------------------------
Guideline on Validation of December Do. Do. http://
the Limulus Amebocyte 1987 www.fda.g
Lysate Test as an End- ov/cber/
Product Endotoxin Test guideline
for Human and Animal s.htm
Parenteral Drugs,
Biological Products, and
Medical Devices
------------------------------------------------------------------------
Recommendations for the December Do. Do. http://
Management of Donors and 2, 1987 www.fda.g
Units That Are Initially ov/cber/
Reactive for Hepatitis B memo.htm
Surface Antigen (HbsAg)
------------------------------------------------------------------------
Extension of Dating Period December Do. Do. Do.
for Storage of Red Blood 4, 1987
Cells, Frozen
------------------------------------------------------------------------
To Licensed In Vitro December Do. Do. Do.
Diagnostic Manufacturers: 23,
Handling of Human Blood 1987
Source Materials
------------------------------------------------------------------------
Recommendations for April 6, Do. Do. Do.
Implementation of 1988
Computerization in Blood
Establishments
------------------------------------------------------------------------
Control of Unsuitable April 6, Do. Do. Do.
Blood and Blood 1988
Components
------------------------------------------------------------------------
[[Page 826]]
Discontinuance of July 7, Do. Do. Do.
Prelicensing Inspection 1988
for Immunization Using
Licensed Tetanus Toxoid
and Hepatitis B and
Rabies Vaccines
------------------------------------------------------------------------
Physician Substitutes August Do. Do. Do.
15,
1988
------------------------------------------------------------------------
To Licensed Manufacturers August Do. Do. Do.
of Blood Grouping 26,
Reagents: Criteria for 1988
Exemption of Lot Release
------------------------------------------------------------------------
Revised Guideline for the October Do. Do. Do.
Collection of Platelets, 7, 1988
Pheresis
------------------------------------------------------------------------
To Manufacturers of HTLV-I October Do. Do. Do.
Antibody Test Kits: 18,
Antibody to Human T-Cell 1988
Lymphotropic Virus, Type
I (HTLV-I) Release Panel
I
------------------------------------------------------------------------
HTLV-1 Antibody Testing November Do. Do. Do.
29,
1988
------------------------------------------------------------------------
Use of Recombigen HIV-1 LA February Do. Do. Do.
Test 1, 1989
------------------------------------------------------------------------
Guidance for Autologous March Do. Do. Do.
Blood and Blood 15,
Components 1989
------------------------------------------------------------------------
Use of Recombigen HIV-1 August Do. Do. Do.
Latex Agglutination (LA) 1, 1989
Test
------------------------------------------------------------------------
Draft PTC in the August Do. Do. http://
Manufacture and Clinical 8, 1989 www.fda.g
Evaluation of In Vitro ov/cber/
Tests to Detect guideline
Antibodies to the Human s.htm
Immunodeficiency Virus,
Type 1
------------------------------------------------------------------------
PTC in the Collection, August Do. Do. Do.
Processing, and Testing 22,
of Ex Vivo Activated 1989
Mononuclear Leukocytes
for Administration to
Humans
------------------------------------------------------------------------
Requirements for Septembe Do. Do. http://
Computerization of Blood r 8, www.fda.g
Establishments 1989 ov/cber/
memo.htm
------------------------------------------------------------------------
Abbott Laboratories' HIVAG- October Do. Do. Do.
1 Test for HIV-1 4, 1989
Antigen(s) Not
Recommended for Use as a
Donor Screen
------------------------------------------------------------------------
Guideline for Collection October Do. Do. Do.
of Blood or Blood 26,
Products From Donors With 1989
Positive Tests for
Infectious Disease
Markers (``High Risk''
Donors)
------------------------------------------------------------------------
Guideline for the January Do. Do. http://
Determination of Residual 1990 www.fda.g
Moisture in Dried ov/cber/
Biological Products guideline
s.htm
------------------------------------------------------------------------
Autologous Blood February Do. Do. http://
Collection and Processing 12, www.fda.g
Procedures 1990 ov/cber/
memo.htm
------------------------------------------------------------------------
Use of Genetic Systems HIV- June 21, Do. Do. Do.
2 EIA 1990
------------------------------------------------------------------------
FDA Request for March Do. Do. Do.
Information on Blood 15,
Storage Patterns and Red 1991
Cell Contamination by
Yersinia Enterocolitica
------------------------------------------------------------------------
Revision to October 26, April Do. Do. Do.
1989, Guideline for 17,
Collection of Blood or 1991
Blood Products From
Donors With Positive
Tests for Infectious
Disease Markers (``High
Risk'' Donors)
------------------------------------------------------------------------
Deficiencies Relating to March Do. Do. Do.
the Manufacture of Blood 20,
and Blood Components 1991
------------------------------------------------------------------------
Responsibilities of Blood March Do. Do. Do.
Establishments Related to 20,
Errors and Accidents in 1991
the Manufacture of Blood
and Blood Components
------------------------------------------------------------------------
FDA Recommendations Septembe Do. Do. Do.
Concerning Testing for r 10,
Antibody to Hepatitis B 1991
Core Antigen (Anti-HBc)
------------------------------------------------------------------------
[[Page 827]]
Disposition of Blood Septembe Do. Do. Do.
Products Intended for r 11,
Autologous Use That Test 1991
Repeatedly Reactive for
Anti-HCV
------------------------------------------------------------------------
Clarification of FDA December Do. Do. Do.
Recommendations for Donor 12,
Deferral and Product 1991
Distribution Based on the
Results of Syphilis
Testing
------------------------------------------------------------------------
Supplement to the PTC in April 6, Do. Do. http://
the Production and 1992 www.fda.g
Testing of New Drugs and ov/cber/
Biologics Produced by guideline
Recombinant DNA s.htm
Technology: Nucleic Acid
Characterization and
Genetic Stability
------------------------------------------------------------------------
Revised Recommendations April Do. Do. http://
for the Prevention of 23, www.fda.g
Human Immunodeficiency 1992 ov/cber/
Virus (HIV) Transmission memo.htm
by Blood and Blood
Products
------------------------------------------------------------------------
Use of Fluorognost HIV-1 April Do. Do. Do.
Immunofluorescent Assay 23,
(IFA) 1992
------------------------------------------------------------------------
Revised Recommendations April Do. Do. Do.
for Testing Whole Blood, 23,
Blood Components, Source 1992
Plasma, and Source
Leukocytes for Antibody
to Hepatitis C Virus
Encoded Antigen (Anti-
HCV)
------------------------------------------------------------------------
Exemptions to Permit April Do. Do. Do.
Persons With a History of 23,
Viral Hepatitis Before 1992
the Age of Eleven Years
to Serve as Donors of
Whole Blood and Plasma:
Alternative Procedures,
21 CFR 640.120
------------------------------------------------------------------------
Changes in Equipment for July 21, Do. Do. Do.
Processing Blood Donor 1992
Samples
------------------------------------------------------------------------
Nomenclature for Septembe Do. Do. Do.
Monoclonal Blood Grouping r 28,
Reagents 1992
------------------------------------------------------------------------
Volume Limits for November Do. Do. Do.
Automated Collection of 4, 1992
Source Plasma
------------------------------------------------------------------------
FDA's Policy Statement November Do. Do. http://
Concerning Cooperative 25, www.fda.g
Manufacturing 1992 ov/cber/
Arrangements for Licensed guideline
Biologics s.htm
------------------------------------------------------------------------
Revision of October 7, December Do. Do. http://
1988, Memo Concerning Red 16, www.fda.g
Blood Cell Immunization 1992 ov/cber/
Programs memo.htm
------------------------------------------------------------------------
Draft PTC in the July 12, Do. Do. http://
Characterization of Cell 1993 www.fda.g
Lines Used to Produce ov/cber/
Biologicals guideline
s.htm
------------------------------------------------------------------------
Guidance on Alternatives July 20, Do. Do. Do.
to Lot Release for 1993
Licensed Biological
Products
------------------------------------------------------------------------
Recommendations Regarding July 22, Do. Do. http://
License Amendments and 1993 www.fda.g
Procedures for Gamma ov/cber/
Irradiation of Blood memo.htm
Products
------------------------------------------------------------------------
Deferral of Blood and July 28, Do. Do. Do.
Plasma Donors Based on 1993
Medications
------------------------------------------------------------------------
Revised Recommendations August Do. Do. Do.
for Testing Whole Blood, 5, 1993
Blood Components, Source
Plasma, and Source
Leukocytes for Antibody
to Hepatitis C Virus
Encoded Antigen (Anti-
HCV)
------------------------------------------------------------------------
Clarification of the Use August Do. Do. Do.
of Unlicensed Anti-HCV 19,
Supplemental Test Results 1993
in Regard to Donor
Notification
------------------------------------------------------------------------
Draft Guideline for the Septembe Do. Do. http://
Validation of Blood r 28, www.fda.g
Establishment Computer 1993 ov/cber/
Systems guideline
s.htm
------------------------------------------------------------------------
Guidance Regarding Post December Do. Do. http://
Donation Information 10, www.fda.g
Reports 1993 ov/cber/
memo.htm
------------------------------------------------------------------------
[[Page 828]]
Donor Suitability Related December Do. Do. Do.
to Laboratory Testing for 22,
Viral Hepatitis and a 1993
History of Viral
Hepatitis
------------------------------------------------------------------------
Recommendations for the January Do. Do. Do.
Invalidation of Test 3, 1994
Results When Using
Licensed Viral Marker
Assays to Screen Donors
------------------------------------------------------------------------
Recommendations for July 26, Do. Do. Do.
Deferral of Donors for 1994
Malaria Risk
------------------------------------------------------------------------
Office of Establishment August Do. Do. http://
Licensing and Product 1994 www.fda.g
Surveillance (OELPS), ov/cber/
Advertising and guideline
Promotional Labeling s.htm
Staff, Procedural
Guidance Document (Draft)
------------------------------------------------------------------------
Guidance for Industry for November Do. Do. Do.
the Submission of 1994
Chemistry, Manufacturing,
and Controls Information
for Synthetic Peptide
Substances
------------------------------------------------------------------------
Recommendations to Users December Do. Do. http://
of Medical Devices That 20, www.fda.g
Test for Infectious 1994 ov/cber/
Disease Markers by Enzyme memo.htm
Immunoassay (EIA) Test
Systems
------------------------------------------------------------------------
Timeframe for Licensing February Do. Do. Do.
Irradiated Blood Products 3, 1995
------------------------------------------------------------------------
Revision of August 27, March Do. Do. Do.
1982, FDA Memo: 10,
Requirements for 1995
Infrequent Plasmapheresis
Donors
------------------------------------------------------------------------
To All Licensed March Do. Do. Do.
Establishments Performing 14,
Red Blood Cell 1995
Immunizations: Revised
Recommendations for Red
Blood Cell Immunization
Programs for Source
Plasma Donors
------------------------------------------------------------------------
Recommendations for the June 8, Do. Do. Do.
Deferral of Current and 1995
Recent Inmates of
Correctional Institutions
as Donors of Whole Blood,
Blood Components, Source
Leukocytes, and Source
Plasma
------------------------------------------------------------------------
Guideline for Quality July 11, Do. Do. http://
Assurance in Blood 1995 www.fda.g
Establishments ov/cber/
guideline
s.htm
------------------------------------------------------------------------
FDA Guidance Document July 11, Do. Do. Do.
Concerning Use of Pilot 1995
Manufacturing Facilities
for the Development and
Manufacture of Biological
Products
------------------------------------------------------------------------
Recommendations for August Do. Do. http://
Labeling and Use of Units 8, 1995 www.fda.g
of Whole Blood, Blood ov/cber/
Components, Source memo.htm
Plasma, Recovered Plasma,
or Source Leukocytes
Obtained From Donors With
Elevated Levels of
Alanine Aminotransferase
(ALT)
------------------------------------------------------------------------
Recommendations for Donor August Do. Do. Do.
Screening With a Licensed 8, 1995
Test for HIV-1 Antigen
------------------------------------------------------------------------
PTC in the Manufacture and 1995 Do. Do. http://
Testing of Therapeutic www.fda.g
Products for Human Use ov/cber/
Derived From Transgenic guideline
Animals s.htm
------------------------------------------------------------------------
Draft Reviewers' Guide: October FDA Do. Do.
Informed Consent for 1, 1995 personnel
Plasmapheresis/
Immunization
------------------------------------------------------------------------
Draft Reviewers' Guide: October Do. Do. Do.
Disease Associated 1, 1995
Antibody Collection
Program
------------------------------------------------------------------------
Draft Document Concerning December Do. Do. http://
the Regulation of 1995 www.fda.g
Placental/Umbilical Cord ov/cber/
Blood Stem Cell Products memo.htm
Intended for
Transplantation or
Further Manufacturing
Into Injectable Products
------------------------------------------------------------------------
[[Page 829]]
Donor Deferral Due to Red December FDA Do. Do.
Blood Cell Loss During 4, 1995 regulated
Collection of Source industry
Plasma by Automated
Plasmapheresis
------------------------------------------------------------------------
Draft Document Concerning February Do. Do. Do.
the Regulation of 1996
Peripheral Blood
Hematopoietic Stem Cell
Products Intended for
Transplantation or
Further Manufacturing
Into Injectable Products
------------------------------------------------------------------------
International Conference February Do. Do. http://
on Harmonisation (ICH) 23, www.fda.g
Final Guideline on 1996 ov/cber/
Quality of guideline
Biotechnological s.htm
Products: Analysis of the
Expression Construct in
Cells Used for Production
of r-DNA Derived Protein
Products
------------------------------------------------------------------------
ICH Final Guideline on the March 1, Do. Do. Do.
Need for Long-Term Rodent 1996
Carcinogenicity Studies
of Pharmaceuticals
------------------------------------------------------------------------
Additional Recommendations March Do. Do. http://
for Donor Screening With 14, www.fda.g
a Licensed Test for HIV-1 1996 ov/cber/
Antigen memo.htm
------------------------------------------------------------------------
FDA Guidance Concerning April Do. Do. http://
Demonstration of 1996 www.fda.g
Comparability of Human ov/cber/
Biological Products, guideline
Including Therapeutic s.htm
Biotechnology-Derived
Products
------------------------------------------------------------------------
Additional Recommendations May 16, Do. Do. http://
for Testing Whole Blood, 1996 www.fda.g
Blood Components, Source ov/cber/
Plasma, and Source memo.htm
Leukocytes for Antibody
to Hepatitis C Virus
Encoded Antigen (Anti-
HCV)
------------------------------------------------------------------------
Guidance for Industry--The May 1996 Do. Do. http://
Content and Format for www.fda.g
Pediatric Use Supplements ov/cber/
guideline
s.htm
------------------------------------------------------------------------
Guidance on Applications May 1996 Do. Do. Do.
for Products Comprised of
Living Autologous Cells
Manipulated Ex Vivo and
Intended for Structural
Repair or Reconstruction
------------------------------------------------------------------------
Recommendations and May 29, Do. Do. http://
Licensure Requirements 1996 www.fda.g
for Leukocyte-Reduced ov/cber/
Blood Products memo.htm
------------------------------------------------------------------------
ICH Final Guidelines on July 10, Do. Do. http://
Stablity Testing of 1996 www.fda.g
Biotechnological/ ov/cber/
Biological Products guideline
s.htm
------------------------------------------------------------------------
Recommendations for the July 19, Do. Do. http://
Quarantine and 1996 www.fda.g
Disposition of Units From ov/cber/
Prior Collections From memo.htm
Donors With Repeatedly
Reactive Screening Tests
for Hepatitis B Virus
(HBV), Hepatitis C Virus
(HCV), and Human T-
Lymphotropic Virus Type I
(HTLV-I)
------------------------------------------------------------------------
Guidance for Industry for August Do. Do. http://
the Submission of 1996 www.fda.g
Chemistry, Manufacturing, ov/cber/
and Controls Information guideline
for a Therapeutic s.htm
Recombinant DNA-Derived
Product or a Monoclonal
Antibody Product for In
Vivo Use
------------------------------------------------------------------------
Interim Recommendations December Do. Do. http://
for Deferral of Donors at 11, www.fda.g
Increased Risk for HIV-1 1996 ov/cber/
Group O Infection memo.htm
------------------------------------------------------------------------
PTC on Plasmid DNA December Do. Do. http://
Vaccines for Preventive 1996 www.fda.g
Infectious Disease ov/cber/
Indications guideline
s.htm
------------------------------------------------------------------------
Guidance for the January Do. Do. Do.
Submission of Chemistry, 1997
Manufacturing, and
Controls Information and
Establishment Description
for Autologous Somatic
Cell Therapy Products
------------------------------------------------------------------------
Reviewer Guidance for a January FDA Do. Do.
Premarket Notification 13, personnel
Submission for Blood 1997
Establishment Computer
Software
------------------------------------------------------------------------
[[Page 830]]
PTC in the Manufacture and February FDA Do. Do.
Testing of Monoclonal 28, regulated
Antibody Products for 1997 industry
Human Use
------------------------------------------------------------------------
Proposed Approach to February Do. Do. Do.
Regulation of Cellular 28,
and Tissue-Based Products 1997
------------------------------------------------------------------------
Guidance for Industry for April Do. Do. Do.
the Evaluation of 1997
Combination Vaccines for
Preventable Diseases:
Production, Testing, and
Clinical Studies
------------------------------------------------------------------------
ICH Guidelines for the May 16, Do. Do. Do.
Photostability Testing of 1997
New Drug Substances and
Products
------------------------------------------------------------------------
Guidance for Industry: July Do. Do. Do.
Changes to an Approved 1997
Application: Biological
Products
------------------------------------------------------------------------
Guidance for Industry: July Do. Do. Do.
Changes to an Approved 1997
Application for Specified
Biotechnology and
Specified Synthetic
Biological Products
------------------------------------------------------------------------
Guidance for Industry: July Do. Do. Do.
Screening and Testing of 1997
Donors of Human Tissue
Intended for
Transplantation
------------------------------------------------------------------------
Guidance for Industry: August Do. Do. Do.
Donor Screening for 1997
Antibodies to HTLV-II
------------------------------------------------------------------------
Guidance for Industry: August Do. Do. Do.
Postmarketing Adverse 1997
Experience Reporting for
Human Drug and Licensed
Biological Products:
Clarification of What to
Report
------------------------------------------------------------------------
Guidance for Industry: The Septembe Do. Do. Do.
Sourcing and Processing r 1997
of Gelatin to Reduce the
Potential Risk Posed by
Bovine Spongiform
Encephalopathy (BSE) in
FDA-Regulated Products
for Human Use
------------------------------------------------------------------------
Guidance for FDA and November FDA Do. Do.
Industry: Direct Final 21, personnel
Rule Procedures 1997 and
regulated
industry
------------------------------------------------------------------------
Draft Guidance for December FDA Do. Do.
Industry: Promoting 1997 regulated
Medical Products in a industry
Changing Healthcare
Environment; I. Medical
Product Promotion by
Healthcare Organizations
or Pharmacy Benefits
Management Companies
(PBMs)
------------------------------------------------------------------------
Guidance for Industry: November Do. Do. Do.
Industry-Supported 1997
Scientific and
Educational Activities
------------------------------------------------------------------------
Guidance for Industry: January Do. Do. Do.
Year 2000 Date Change for 1998
Computer Systems and
Software Applications
Used in the Manufacture
of Blood Products
------------------------------------------------------------------------
Draft Guidance for January Do. Do. Do.
Industry: Container and 28,
Closure Integrity Testing 1998
In Lieu of Sterility
Testing as a Component of
the Stability Protocol
for Sterile Products
------------------------------------------------------------------------
Draft Guidance for March Do. Do. Do.
Industry: Manufacturing, 1998
Processing, or Holding
Active Pharmaceutical
Ingredients
------------------------------------------------------------------------
Guidance for Industry: March Do. Do. Do.
Guidance for Human 1998
Somatic Cell Therapy and
Gene Therapy
------------------------------------------------------------------------
Draft Guidance for May 1998 Do. Do. Do.
Industry: Instructions
for Submitting Electronic
Lot Release Protocols to
CBER
------------------------------------------------------------------------
[[Page 831]]
Guidance for Industry: May 14, Do. Do. Do.
Classifying Resubmissions 1998
in Response to Action
Letters
------------------------------------------------------------------------
Guidance for Industry: May 1998 Do. Do. Do.
Pharmacokinetics in
Patients With Impaired
Renal Function--Study
Design, Data Analysis,
and Impact on Dosing and
Labeling
------------------------------------------------------------------------
Guidance for Industry: May 15, Do. Do. Do.
Standards for the Prompt 1998
Review of Efficacy
Supplements, Including
Priority Efficacy
Supplements
------------------------------------------------------------------------
Guidance for Industry: May 1998 Do. Do. Do.
Providing Clinical
Evidence of Effectiveness
for Human Drugs and
Biological Products
------------------------------------------------------------------------
Draft Guidance for June Do. Do. Do.
Industry: Stability 1998
Testing of Drug
Substances and Drug
Products
------------------------------------------------------------------------
Guidance for Industry: June Do. Do. Do.
Errors and Accidents 1998
Regarding Saline Dilution
of Samples Used for Viral
Marker Testing
------------------------------------------------------------------------
ICH Guidance on Ethnic June 10, Do. Do. Do.
Factors in the 1998
Acceptability of Foreign
Clinical Data
------------------------------------------------------------------------
Draft Guidance for June 12, Do. Do. Do.
Industry: Exports and 1998
Imports Under the FDA
Export Reform and
Enhancement Act of 1996
------------------------------------------------------------------------
Guidance for Industry: July Do. Do. Do.
Implementation of Section 1998
126 of the Food and Drug
Administration
Modernization Act of
1997--Elimination of
Certain Labeling
Requirements
------------------------------------------------------------------------
Guidance for Industry: July Do. Do. Do.
Environmental Assessment 1998
of Human Drug and
Biologics Applications
------------------------------------------------------------------------
Draft Guidance for Septembe Do. Do. Do.
Industry: Submitting r 1998
Debarment Certification
Statements
------------------------------------------------------------------------
Guidance for Industry: How Septembe Do. Do. Do.
to Complete the Vaccine r 1998
Adverse Event Reporting
System Form (VAERS-1)
------------------------------------------------------------------------
Guidance for Industry: July Do. Do. Do.
Fast Track Drug 2004
Development Programs--
Designation, Development,
and Application Review
------------------------------------------------------------------------
ICH Guidance on Septembe Do. Do. Do.
Statistical Principles r 16,
for Clinical Trials 1998
------------------------------------------------------------------------
ICH Guidance on Quality of Septembe Do. Do. Do.
Biotechnological/ r 21,
Biological Products: 1998
Derivation and
Characterization of Cell
Substrates Used for
Production of
Biotechnological/
Biological Products
------------------------------------------------------------------------
ICH Guidance on Viral Septembe Do. Do. Do.
Safety Evaluation of r 24,
Biotechnology Products 1998
Derived From Cell Lines
of Human or Animal Origin
------------------------------------------------------------------------
Draft Guidance for November Do. Do. Do.
Industry: General 1998
Considerations for
Pediatric Pharmacokinetic
Studies for Drugs and
Biological Products
------------------------------------------------------------------------
Guidance for Industry: FDA December Do. Do. Do.
Approval of New Cancer 1998
Treatment Uses for
Marketed Drug and
Biological Products
------------------------------------------------------------------------
Draft Guidance for January Do. Do. Do.
Industry: Product Name 1999
Placement, Size, and
Prominence in Advertising
and Promotional Labeling
------------------------------------------------------------------------
[[Page 832]]
Guidance for Industry: January Do. Do. Do.
Content and Format of 1999
Chemistry, Manufacturing,
and Controls Information
and Establishment
Description Information
for a Vaccine or Related
Product
------------------------------------------------------------------------
Guidance on Amended January Do. Do. Do.
Procedures for Advisory 26,
Panel Meetings 1999
------------------------------------------------------------------------
Draft Guidance for October Do. Do. http://
Industry; Providing 2003 www.fda.g
Regulatory Submissions in ov/cber/
Electronic Format-- esub/
General Considerations esubguid.
htm
------------------------------------------------------------------------
Guidance for Industry: February Do. Do. http://
Population 1999 www.fda.g
Pharmacokinetics ov/cber/
guideline
s.htm
------------------------------------------------------------------------
Guidance for Industry: February Do. Do. Do.
Clinical Development 1999
Programs for Drugs,
Devices, and Biological
Products for the
Treatment of Rheumatoid
Arthritis (RA)
------------------------------------------------------------------------
Guidance for Industry: For February Do. Do. Do.
the Submission of 1999
Chemistry, Manufacturing,
and Controls and
Establishment Description
Information for Human
Plasma-Derived Biological
Products, Animal Plasma,
or Serum-Derived Products
------------------------------------------------------------------------
Draft Guidance for March Do. Do. Do.
Industry: Accelerated 1999
Approval Products--
Submission of Promotional
Materials
------------------------------------------------------------------------
Guidance for Industry: March Do. Do. Do.
Content and Format of 1999
Chemistry, Manufacturing,
and Controls Information
and Establishment
Description Information
for a Biological In Vitro
Diagnostic Product
------------------------------------------------------------------------
Guidance for Industry: April Do. Do. Do.
Public Health Issues 1999
Posed by the Use of
Nonhuman Primate
Xenografts in Humans
------------------------------------------------------------------------
Guidance for Industry on April Do. Do. Do.
the Content and Format of 1999
Chemistry, Manufacturing,
and Controls Information
and Establishment
Description Information
for an Allergenic Extract
or Allergen Patch Test
------------------------------------------------------------------------
Guidance for Industry for May 1999 Do. Do. Do.
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''
------------------------------------------------------------------------
Draft Guidance for May 1999 Do. Do. Do.
Industry for Platelet
Testing and Evaluation of
Platelet Substitute
Products
------------------------------------------------------------------------
Guidance for Industry: May 1999 Do. Do. Do.
Efficacy Studies to
Support Marketing of
Fibrin Sealant Products
Manufactured for
Commercial Use
------------------------------------------------------------------------
Draft Reviewer Guidance: June FDA Do. Do.
Evaluation of Human 1999 personnel
Pregnancy Outcome Data
------------------------------------------------------------------------
Draft Guidance for June FDA Do. Do.
Industry: Current Good 1999 regulated
Manufacturing Practice industry
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)
------------------------------------------------------------------------
[[Page 833]]
ICH Guidance on the June 25, Do. Do. Do.
Duration of Chronic 1999
Toxicity Testing in
Animals (Rodent and
Nonrodent Toxicity
Testing)
------------------------------------------------------------------------
Draft Guidance for July Do. Do. Do.
Industry: Clinical 1999
Development Programs for
Drugs, Devices, and
Biological Products
Intended for the
Treatment of
Osteoarthritis (OA)
------------------------------------------------------------------------
Draft Guidance for July Do. Do. Do.
Industry: Interpreting 1999
Sameness of Monoclonal
Antibody Products Under
the Orphan Drug
Regulations
------------------------------------------------------------------------
Draft Guidance for August Do. Do. Do.
Industry: Cooperative 1999
Manufacturing
Arrangements for Licensed
Biologics
------------------------------------------------------------------------
Guidance for Industry: August Do. Do. Do.
Consumer-Directed 1999
Broadcast Advertisements
------------------------------------------------------------------------
Guidance for Industry: August Do. Do. Do.
Possible Dioxin/PCB 1999
Contamination of Drug and
Biological Products
------------------------------------------------------------------------
Guidance for Industry: August Do. Do. Do.
Submission of Abbreviated 1999
Reports and Synopses in
Support of Marketing
Applications
------------------------------------------------------------------------
ICH Guidance on August Do. Do. Do.
Specifications: Test 18,
Procedures and Acceptance 1999
Criteria for
Biotechnological/
Biological Products
------------------------------------------------------------------------
Guidance for Industry: Septembe Do. Do. Do.
Qualifying for Pediatric r 1999
Exclusivity Under Section
505A of the Federal Food,
Drug, and Cosmetic Act
------------------------------------------------------------------------
Guidance for Industry: November Do. Do. Do.
Providing Regulatory 1999
Submissions to CBER in
Electronic Format--
Biologics Marketing
Applications (Biologics
License Application
(BLA), Product License
Application (PLA)/
Establishment License
Application (ELA), and
New Drug Application
(NDA)); revised
------------------------------------------------------------------------
Guidance for Industry: In November Do. Do. Do.
Vivo Drug Metabolism/Drug 1999
Interaction Studies--
Study Design, Data
Analysis, and
Recommendations for
Dosing and Labeling
------------------------------------------------------------------------
ICH of Technical November Do. Do. Do.
Requirements for 8, 1999
Registration of
Pharmaceuticals for Human
Use; M4: Common Technical
Document
------------------------------------------------------------------------
Guidance for Industry: In December Do. Do. Do.
the Manufacture and 1999
Clinical Evaluation of In
Vitro Tests to Detect
Nucleic Acid Sequences of
Human Immunodeficiency
Viruses Types 1 and 2
------------------------------------------------------------------------
Guidance for Reviewers: November FDA Do. Do.
Potency Limits for 2000 personnel
Standardized Dust Mite
and Grass Allergen
Vaccines: A Revised
Protocol
------------------------------------------------------------------------
Guidance for Industry: February FDA Do. Do.
Formal Meetings With 2000 regulated
Sponsors and Applicants industry
for PDUFA Products
------------------------------------------------------------------------
Guidance for Industry: February Do. Do. Do.
Formal Dispute 2000
Resolution: Appeals Above
the Division Level
------------------------------------------------------------------------
Guidance for Industry: February Do. Do. Do.
Gamma Irradiation of 2000
Blood and Blood
Components: A Pilot
Program for Licensing
------------------------------------------------------------------------
[[Page 834]]
Draft Guidance for May 2000 Do. Do. Do.
Industry: Content and
Format of the Adverse
Reactions Section of
Labeling for Human
Prescription Drugs and
Biologics
------------------------------------------------------------------------
Guidance for Industry: June Do. Do. Do.
Recognition and Use of a 2000
Standard for the Uniform
Labeling of Blood and
Blood Components
------------------------------------------------------------------------
Draft Guidance for June Do. Do. Do.
Industry: Recommendations 2000
for Donor Questioning
Regarding Possible
Exposure to Malaria
------------------------------------------------------------------------
Draft Guidance for June Do. Do. Do.
Industry: Pediatric 2000
Oncology Studies in
Response to a Written
Request
------------------------------------------------------------------------
Guidance for Industry: June Do. Do. Do.
Availability of Licensed 2000
Donor Screening Tests
Labeled for Use With
Cadaveric Blood Specimens
------------------------------------------------------------------------
Draft Guidance for June Do. Do. Do.
Industry: Chronic 2000
Cutaneous Ulcer and Burn
Wounds--Developing
Products for Treatment
------------------------------------------------------------------------
Draft Guidance for August Do. Do. Do.
Industry: Analytical 2000
Procedures and Methods
Validation--Chemistry,
Manufacturing, and
Controls Documentation
------------------------------------------------------------------------
Draft Guidance for August Do. Do. Do.
Industry: Considerations 2000
for Reproductive Toxicity
Studies for Preventive
Vaccines for Infectious
Disease Indications
------------------------------------------------------------------------
Guidance for Industry: Q & October Do. Do. Do.
A Content and Format of 2000
INDs for Phase 1 Studies
of Drugs, Including Well-
Characterized,
Therapeutic,
Biotechnology-Derived
Products
------------------------------------------------------------------------
Guidance for Industry: October Do. Do. Do.
Supplemental Guidance on 2000
Testing for Replication
Competent Retrovirus in
Retroviral Vector Based
Gene Therapy Products and
During Followup of
Patients in Clinical
Trials Using Retroviral
Vectors
------------------------------------------------------------------------
Guidance for Industry: October Do. Do. Do.
Submitting and Reviewing 2000
Complete Responses to
Clinical Holds
------------------------------------------------------------------------
Guidance for Industry: November Do. Do. Do.
Testing Limits in 2000
Stability Protocols for
Standardized Grass Pollen
Extracts
------------------------------------------------------------------------
Guidance for Industry: Use November Do. Do. Do.
of Sterile Connecting 2000
Devices in Blood Bank
Practices
------------------------------------------------------------------------
Draft Guidance for November Do. Do. Do.
Industry: Recommendations 2000
for Complying With the
Pediatric Rule (21 CFR
314.55(a) and 601.27(a))
------------------------------------------------------------------------
ICH Guidance for Industry: December Do. Do. Do.
E11 Clinical 2000
Investigation of
Medicinal Products in the
Pediatric Population
------------------------------------------------------------------------
Guidance for Industry: December Do. Do. Do.
Submitting Separate 2000
Marketing Applications
and Clinical Data for
Purposes of Assessing
User Fees
------------------------------------------------------------------------
ICH Guidance on Q6A December Do. Do. Do.
Specifications: Test 29,
Procedures and Acceptance 2000
Criteria for New Drug
Substances and New Drug
Products: Chemical
Substances
------------------------------------------------------------------------
PHS Guideline on January Do. Do. Do.
Infectious Disease Issues 19,
in Xenotransplantation 2001
------------------------------------------------------------------------
[[Page 835]]
Draft Guidance for January Do. Do. Do.
Industry: Pre-Storage 2001
Leukocyte Reduction of
Whole Blood and Blood
Components Intended for
Transfusion
------------------------------------------------------------------------
Guidance for Industry: January Do. Do. Do.
Recommendations for 2001
Collecting Red Blood
Cells by Automated
Apheresis Methods
------------------------------------------------------------------------
Draft Guidance for January Do. Do. Do.
Industry: Providing 2001
Regulatory Submissions in
Electronic Format--
Prescription Drug
Advertising and
Promotional Labeling
------------------------------------------------------------------------
Guidance for Industry: February Do. Do. Do.
Recommendations for 2001
Collecting Red Blood
Cells by Automated
Apheresis Methods--
Technical Correction
------------------------------------------------------------------------
Draft Guidance for February Do. Do. Do.
Industry: Disclosing 2001
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
------------------------------------------------------------------------
Draft Guidance for March Do. Do. Do.
Industry: Postmarketing 2001
Safety Reporting for
Human Drug and Biological
Products Including
Vaccines
------------------------------------------------------------------------
Guidance for Industry: March Do. Do. Do.
Acceptance of Foreign 2001
Clinical Studies
------------------------------------------------------------------------
Guidance for Industry: March Do. Do. Do.
Financial Disclosure by 2001
Clinical Investigators
------------------------------------------------------------------------
Guidance for Industry: March Do. Do. Do.
Monoclonal Antibodies 2001
Used as Reagents in Drug
Manufacturing
------------------------------------------------------------------------
Draft Guidance for April Do. Do. Do.
Industry: Reports on the 2001
Status of Postmarketing
Studies--Implementation
of Section 130 of the
Food and Drug
Administration
Modernization Act of 1997
------------------------------------------------------------------------
Draft Guidance for May 2001 Do. Do. Do.
Industry: Providing
Regulatory Submissions in
Electronic Format--
Postmarketing Expedited
Safety Reports
------------------------------------------------------------------------
Guidance for Industry: E10 May 2001 Do. Do. Do.
Choice of Control Group
and Related Issues in
Clinical Trials
------------------------------------------------------------------------
Draft Guidance for May 2001 Do. Do. Do.
Industry: IND Meetings
for Human Drugs and
Biologics; Chemistry,
Manufacturing, and
Controls Information
------------------------------------------------------------------------
Draft Guidance for July Do. Do. Do.
Industry: Clinical 2001
Studies Section of
Labeling for Prescription
Drugs and Biologics--
Content and Format
------------------------------------------------------------------------
Guidance for Industry: July Do. Do. Do.
CBER Pilot Licensing 2001
Program for Immunization
of Source Plasma Donors
Using Immunogen Red Blood
Cells Obtained From an
Outside Supplier
------------------------------------------------------------------------
Guidance for Industry: July Do. Do. Do.
Revised Recommendations 2001
Regarding Invalidation of
Test Results of Licensed
and 510(k) Cleared
Bloodborne Pathogen
Assays Used to Test
Donors
------------------------------------------------------------------------
ICH Guidance for Industry: July Do. Do. Do.
S7A Safety Pharmacology 2001
Studies for Human
Pharmaceuticals
------------------------------------------------------------------------
[[Page 836]]
Guidance for FDA July Do. Do. Do.
Reviewers: Premarket 2001
Notification Submissions
for Empty Containers for
the Collection and
Processing of Blood and
Blood Components
------------------------------------------------------------------------
Guidance for FDA July Do. Do. Do.
Reviewers: Premarket 2001
Notification Submissions
for Transfer Sets
(Excluding Sterile
Connecting Devices)
------------------------------------------------------------------------
Guidance for FDA July Do. Do. Do.
Reviewers: Premarket 2001
Notification Submissions
for Blood and Plasma
Warmers
------------------------------------------------------------------------
Guidance for Industry: July Do. Do. Do.
Changes to an Approved 2001
Application: Biological
Products: Human Blood and
Blood Components Intended
for Transfusion or for
Further Manufacture
------------------------------------------------------------------------
Draft Guidance for FDA August Do. Do. Do.
Reviewers: Premarket 2001
Notification Submissions
for Automated Testing
Instruments Used in Blood
Establishments
------------------------------------------------------------------------
Draft Guidance for August Do. Do. Do.
Industry: Biological 2001
Product Deviation
Reporting for Licensed
Manufacturers of
Biological Products Other
Than Blood and Blood
Components
------------------------------------------------------------------------
Draft Guidance for August Do. Do. Do.
Industry: Biological 2001
Product Deviation
Reporting for Blood and
Plasma Establishments
------------------------------------------------------------------------
Guidance for Industry: August Do. Do. Do.
Variances for Blood 2001
Collection From
Individuals With
Hereditary
Hemochromatosis
------------------------------------------------------------------------
Draft Guidance for August Do. Do. Do.
Industry: Submitting Type 2001
V Drug Master Files to
the CBER
------------------------------------------------------------------------
Draft Guidance for August Do. Do. Do.
Industry: Premarket 2001
Notifications (510(k)s)
for In Vitro HIV Drug
Resistance Genotype
Assays: Special Controls
------------------------------------------------------------------------
Draft Guidance for August Do. Do. Do.
Industry: Submitting 2001
Marketing Applications
According to the ICH-CTD
Format--General
Considerations
------------------------------------------------------------------------
ICH Guidance: Q7A Good August Do. Do. Do.
Manufacturing Practice 2001
Guide for Active
Pharmaceutical
Ingredients
------------------------------------------------------------------------
ICH Guidance on M4 Common August Do. Do. Do.
Technical Document 2001
------------------------------------------------------------------------
Guidance for Industry: October Do. Do. Do.
Cancer Drug and 2001
Biological Products--
Clinical Data in
Marketing Applications
------------------------------------------------------------------------
Guidance for Industry: October Do. Do. Do.
Content and Format of 2001
Geriatric Labeling
------------------------------------------------------------------------
Guidance for Industry: October Do. Do. Do.
Recommendations for 2001
Assessment of Donor
Suitability and Blood and
Blood Product Safety in
Cases of Possible
Exposure to Anthrax
------------------------------------------------------------------------
Draft Guidance for November Do. Do. Do.
Clinical Trial Sponsors 2001
on the Establishment and
Operation of Clinical
Trial Data Monitoring
Committees
------------------------------------------------------------------------
Guidance for Industry: November Do. Do. Do.
Information Request and 2001
Discipline Review Letters
Under the Prescription
Drug User Fee Act
------------------------------------------------------------------------
[[Page 837]]
Guidance for Industry: January Do. Do. Do.
Revised Preventive 2002
Measures to Reduce the
Possible Risk of
Transmission of
Creutzfeldt-Jakob Disease
(CJD) and Variant
Creutzfeldt-Jakob Disease
(vCJD) by Blood and Blood
Products
------------------------------------------------------------------------
Guidance for Industry: January Do. Do. Do.
General Principles of 2002
Software Validation;
Final Guidance for
Industry and FDA Staff
------------------------------------------------------------------------
Draft Guidance for February Do. Do. Do.
Industry: Precautionary 2002
Measures to Reduce the
Possible Risk of
Transmission of Zoonoses
by Blood and Blood
Products From
Xenotransplantation
Product Recipients and
Their Intimate Contacts
------------------------------------------------------------------------
Guidance for Industry: March Do. Do. Do.
Validation of Procedures 2002
for Processing of Human
Tissues Intended for
Transplantation
------------------------------------------------------------------------
Guidance for Industry; March Do. Do. http://
Information Program on 2002 www.fda.g
Clinical Trials for ov/cber/
Serious or Life- gdlns/
Threatening Diseases and clintrial
Conditions 031802.pd
f
------------------------------------------------------------------------
Guidance for Industry: March Do. Do. http://
Providing Regulatory 2002 www.fda.g
Submissions to CBER in ov/cber/
Electronic Format-- guideline
Investigational New Drug s.htm
Applications (INDs)
------------------------------------------------------------------------
Guidance for Industry: April Do. Do. Do.
E2BM Data Elements for 2002
Transmission of
Individual Case Safety
Reports
------------------------------------------------------------------------
Draft Guidance for April Do. Do. Do.
Industry: A Modified Lot- 2002
Release Specification for
Hepatitis B Surface
Antigen (HBsAg) Assays
Used to Test Blood, Blood
Components, and Source
Plasma Donations
------------------------------------------------------------------------
Guidance for Industry: May 1999 Do. Do. Do.
Container Closure Systems
for Packaging Human Drugs
and Biologics; Chemistry,
Manufacturing, and
Controls Documentation
------------------------------------------------------------------------
Guidance for Industry: May 2002 Do. Do. Do.
Container Closure Systems
for Packaging Human Drugs
and Biologics; Questions
and Answers
------------------------------------------------------------------------
Draft Guidelines for May 2002 Do. Do. Do.
Ensuring the Quality of
Information Disseminated
to the Public (HHS
Guideline)
------------------------------------------------------------------------
Guidance for Industry: May 2002 Do. Do. Do.
Special Protocol
Assessment
------------------------------------------------------------------------
Draft Guidance for June Do. Do. Do.
Industry: Preventive 2002
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)
------------------------------------------------------------------------
Draft Guidance for August Do. Do. Do.
Industry: 21 CFR Part 11; 2002
Electronic Records;
Electronic Signatures,
Electronic Copies of
Electronic Records
------------------------------------------------------------------------
Guidance for Industry: August Do. Do. Do.
Establishing Pregnancy 2002
Exposure Registries
------------------------------------------------------------------------
Draft Guidance for Septembe Do. Do. Do.
Industry: Drugs, r 2002
Biologics, and Medical
Devices Derived From
Bioengineered Plants for
Use in Humans and Animals
------------------------------------------------------------------------
Draft Guidance for Septembe Do. Do. Do.
Industry: Nonclinical r 2002
Studies for Development
of Pharmaceutical
Excipients
------------------------------------------------------------------------
[[Page 838]]
The Least Burdensome October Do. Do. Do.
Provisions of the FDA 2002
Modernization Act of
1997: Concept and
Principles; Final
Guidance for FDA and
Industry
------------------------------------------------------------------------
Guidance for Industry and December Do. Do. http://
FDA Staff; Class II 18, www.fda.g
Special Controls Guidance 2003 ov/cber/
Document: Human Dura gdlns/
Mater humdurama
t.pdf
------------------------------------------------------------------------
Guidance for Industry: December Do. Do. http://
Recommendations for 2002 www.fda.g
Deferral of Donors and ov/cber/
Quarantine and Retrieval guideline
of Blood and Blood s.htm
Products in Recent
Recipients of Smallpox
Vaccine (Vaccinia Virus)
and Certain Contacts of
Smallpox Vaccine
Recipients
------------------------------------------------------------------------
Draft Guidance for December Do. Do. Do.
Industry and Reviewers on 2002
Estimating the Safe
Starting Dose in Clinical
Trials for Therapeutics
in Adult Healthy
Volunteers
------------------------------------------------------------------------
ICH Guidance for Industry; January Do. Do. Do.
Q1D Bracketing and 2003
Matrixing Designs for
Stability Testing of New
Drug Substances and
Products
------------------------------------------------------------------------
Draft Guidance for January Do. Do. Do.
Industry: Collection of 2003
Race and Ethnicity Data
in Clinical Trials
------------------------------------------------------------------------
Draft Guidance for January Do. Do. Do.
Industry: Drug Product: 2003
Chemistry, Manufacturing,
and Controls Information
------------------------------------------------------------------------
ICH Guidance for Industry: February Do. Do. Do.
M4 CTD--Safety: Questions 2003
and Answers
------------------------------------------------------------------------
Guidance for Industry and February Do. Do. Do.
FDA Staff: Quality System 2003
Information for Certain
Premarket Application
Reviews
------------------------------------------------------------------------
ICH Guidance for Industry: February Do. Do. Do.
Q3A Impurities in New 2003
Drug Substances
------------------------------------------------------------------------
Draft Guidance for February Do. Do. Do.
Industry; Comparability 2003
Protocols--Chemistry,
Manufacturing, and
Controls Information
------------------------------------------------------------------------
Assessing User Fees: PMA February Do. Do. http://
Supplement Definitions, 25, www.fda.g
Modular PMA Fees, BLA and 2003 ov/cber/
Efficacy Supplement dap/
Definitions, Bundling devpubs.h
Multiple Devices in a tm
Single Application, and
Fees for Combination
Products; Guidance for
Industry and FDA
------------------------------------------------------------------------
Guidance for Industry and March Do. Do. http://
FDA: FY 2003 MDUFMA Small 2003 www.fda.g
Business Qualification ov/cber/
Worksheet and guideline
Certification s.htm
------------------------------------------------------------------------
ICH Guidance for Industry: April Do. Do. Do.
M2 eCTD: Electronic 2003
Common Technical Document
Specification
------------------------------------------------------------------------
Guidance for Industry: April Do. Do. Do.
Source Animal, Product, 2003
Preclinical, and Clinical
Issues Concerning the Use
of Xenotransplantation
Products in Humans
------------------------------------------------------------------------
Guidance for Industry: April Do. Do. Do.
Recommendations for the 2003
Assessment of Donor
Suitability and Blood
Product Safety in Cases
of Suspected Severe Acute
Respiratory Syndrome
(SARS) or Exposure to
SARS
------------------------------------------------------------------------
Guidance for Industry, FDA October Do. Do. http://
Staff, and Third Parties; 4, 2004 www.fda.g
Implementation of the ov/cber/
Inspection by Accredited dap/
Persons Program Under the devpubs.h
Medical Device User Fee tm
and Modernization Act of
2002; Accreditation
Criteria
------------------------------------------------------------------------
[[Page 839]]
Guidance for Industry: April Do. Do. http://
Exposure-Response 2003 www.fda.g
Relationships--Study ov/cber/
Design, Data Analysis, guideline
and Regulatory s.htm
Applications
------------------------------------------------------------------------
Guidance for Industry: May 2003 Do. Do. Do.
Revised Recommendations
for the Assessment of
Donor Suitability and
Blood and Blood Product
Safety in Cases of Known
or Suspected West Nile
Virus Infection
------------------------------------------------------------------------
Guidance for Industry: May 2003 Do. Do. Do.
Pharmacokinetics in
Patients With Impaired
Hepatic Function: Study
Design, Data Analysis,
and Impact on Dosing and
Labeling
------------------------------------------------------------------------
Draft Guidance for June Do. Do. Do.
Industry and FDA Staff: 2003
Compliance with Section
301 of the Medical Device
User Fee and
Modernization Act of
2002--Identification of
Manufacturer of Medical
Devices
------------------------------------------------------------------------
Guidance for FDA Staff: June Do. Do. Do.
The Leveraging Handbook, 2003
An Agency Resource for
Effective Collaborations
------------------------------------------------------------------------
Draft Guidance for June Do. Do. Do.
Industry: Providing 2003
Regulatory Submissions in
Electronic Format--
Postmarketing Periodic
Adverse Drug Experience
Reports
------------------------------------------------------------------------
Draft Guidance for June Do. Do. Do.
Industry: Revised 2003
Recommendations for Donor
and Product Management
Based on Screening Tests
for Syphilis
------------------------------------------------------------------------
Guidance for Industry and July Do. Do. Do.
FDA Staff: Medical Device 2003
User Fee and
Modernization Act of
2002, Validation Data in
Premarket Notification
Submissions (510(k)s) for
Reprocessed Single-Use
Medical Devices
------------------------------------------------------------------------
Guidance for Industry: July Do. Do. Do.
Streamlining the Donor 2003
Interview Process:
Recommendations for Self-
Administered
Questionnaires
------------------------------------------------------------------------
Draft Guidance for July Do. Do. Do.
Industry and FDA Staff: 2003
Premarket Assessment of
Pediatric Medical Devices
------------------------------------------------------------------------
Draft Guidance for Review July Do. Do. Do.
Staff and Industry: Good 2003
Review Management
Principles for PDUFA
Products
------------------------------------------------------------------------
Compliance Program Dates Do. Do. http://
Guidance Manual (drugs vary--I www.fda.g
and biologics) ndividu ov/cber/
al cpg/
issue cpg.htm
dates
------------------------------------------------------------------------
ICH Guidance for Industry: November Do. Do. http://
Q3C--Tables and List 2003 www.fda.g
ov/cber/
guideline
s.htm
------------------------------------------------------------------------
ICH Guidance for Industry: November Do. Do. Do.
Q3B(R) Impurities in New 2003
Drug Products
------------------------------------------------------------------------
ICH Guidance for Industry: November Do. Do. Do.
Q1A(R2) Stability Testing 2003
of New Drug Substances
and Products
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
WITHDRAWN GUIDANCES
------------------------------------------------------------------------
Draft Guidance for November Do. N/A
Industry: Application of 1999
Current Statutory
Authority to Nucleic Acid
Testing of Pooled Plasma
------------------------------------------------------------------------
Draft Document Concerning December Do. Do.
the Regulation of 1995
Placental/Umbilical Cord
Blood Hematopoietic Stem
Cell Products Intended
for Transplantation or
Further Manufacturing
Into Injectable Products
------------------------------------------------------------------------
[[Page 840]]
Draft Document Concerning February Do. Do.
the Regulation of 1996
Peripheral Blood
Hematopoietic Stem Cell
Products Intended for
Transplantation or
Further Manufacturing
into Injectable Products
------------------------------------------------------------------------
Draft Advertising and August Do. Do.
Promotional Labeling 1994
Staff Procedural Guidance
------------------------------------------------------------------------
Draft Guidance for August Do. Do.
Industry: 21 CFR Part 11; 2001
Electronic Records;
Electronic Signatures;
Validation
------------------------------------------------------------------------
Draft Guidance for August Do. Do.
Industry: 21 CFR Part 11; 2001
Electronic Records;
Electronic Signatures;
Glossary of Terms
------------------------------------------------------------------------
Draft Guidance for February Do. Do.
Industry: 21 CFR Part 11; 2002
Electronic Records;
Electronic Signatures;
Time Stamps
------------------------------------------------------------------------
Draft Guidance for July Do. Do.
Industry: 21 CFR Part 11; 2002
Electronic Records;
Electronic Signatures,
Maintenance of Electronic
Records
------------------------------------------------------------------------
Guidance Documents Issued by CDER
------------------------------------------------------------------------
How to Obtain a Copy
Intended of the Document
Name of Document Date of User or -----------------------
Issuance Regulatory Mailing Internet
Activity Address Address
------------------------------------------------------------------------
Aerosol Steroid Product January Advertisin Division http://
Safety Information in 12, g of Drug www.fda.g
Prescription Drug 1998 Informati ov/cder/
Advertising and on (HFD- guidance/
Promotional Labeling 200), index.htm
Office of
Training
and
Communica
tions,
Center
for Drug
Evaluatio
n and
Research,
Food and
Drug
Administr
ation,
5600
Fishers
Lane,
Rockville
, MD
20857,
301-827-4
573
------------------------------------------------------------------------
Consumer-Directed August Do. Do. Do.
Broadcast Advertisements 9, 1999
------------------------------------------------------------------------
Industry-Supported December Do. Do. Do.
Scientific and 3, 1997
Educational Activities
------------------------------------------------------------------------
Accelerated Approval March Advertisin Do. Do.
Products--Submission of 26, g draft
Promotional Materials 1999
------------------------------------------------------------------------
Brief Summary: Disclosing February Do. Do. Do.
Risk Information in 10,
Consumer-Directed Print 2004
Advertisements
------------------------------------------------------------------------
``Help-Seeking'' and Other February Do. Do. Do.
Disease Awareness 10,
Communications by or on 2004
Behalf of Drug and Device
Firms
------------------------------------------------------------------------
Product Name Placement, March Do. Do. Do.
Size, and Prominence in 12,
Advertising and 1999
Promotional Labeling
------------------------------------------------------------------------
Promoting Medical Products January Do. Do. Do.
in a Changing Healthcare 5, 1998
Environment; I. Medical
Product Promotion by
Healthcare Organizations
or Pharmacy Benefits
Management Companies
(PBMs)
------------------------------------------------------------------------
Bioanalytical Method May 23, Biopharmac Do. Do.
Validation 2001 eutics
------------------------------------------------------------------------
[[Page 841]]
Bioavailability and March Do. Do. Do.
Bioequivalence Studies 19,
for Orally Administered 2003
Drug Products--General
Considerations
------------------------------------------------------------------------
Cholestyramine Powder In July 15, Do. Do. Do.
Vitro Bioequivalence 1993
------------------------------------------------------------------------
Clozapine Tablets In Vivo November Do. Do. Do.
Bioequivalence and In 15,
Vitro Dissolution Testing 1996
------------------------------------------------------------------------
Corticosteroids, June 2, Do. Do. Do.
Dermatologic (topical) In 1995
Vivo
------------------------------------------------------------------------
Dissolution Testing of August Do. Do. Do.
Immediate Release Solid 25,
Oral Dosage Forms 1997
------------------------------------------------------------------------
Extended Release Oral Septembe Do. Do. Do.
Dosage Forms: r 26,
Development, Evaluation, 1997
and Application of In
Vitro/In Vivo
Correlations
------------------------------------------------------------------------
Food-Effect December Do. Do. Do.
Bioavailability and Fed 2002
Bioequivalence Studies
------------------------------------------------------------------------
Metaproterenol Sulfate and June 27, Do. Do. Do.
Albuterol Metered Dose 1989
Inhalers In Vitro
------------------------------------------------------------------------
Phenytoin/Phenytion Sodium March 4, Do. Do. Do.
(capsules, tablets, 1994
suspension) In Vivo
Bioequivalence and In
Vitro Dissolution Testing
------------------------------------------------------------------------
Statistical Approaches to February Do. Do. Do.
Establishing 2, 2001
Bioequivalence
------------------------------------------------------------------------
Waiver of In Vivo August Do. Do. Do.
Bioavailability and 31,
Bioequivalence Studies 2000
for Immediate-Release
Solid Oral Dosage Forms
Based on a
Biopharmaceutics
Classification System
------------------------------------------------------------------------
Antifungal (topical) February Biopharmac Do. N/A
24, eutics
1990 draft
------------------------------------------------------------------------
Antifungal (vaginal) February Do. Do. Do.
24,
1990
------------------------------------------------------------------------
Bioavailability and April Do. Do. http://
Bioequivalence Studies 2003 www.fda.g
for Nasal Aerosols and ov/cder/
Nasal Sprays for Local guidance/
Action index.htm
------------------------------------------------------------------------
Clozapine Tablets: In Vivo December Do. Do. Do.
Bioequivalence and In 2003
Vitro Dissolution Testing
------------------------------------------------------------------------
Conjugated Estrogens, USP- March Do. Do. Do.
LC-MS Method for Both 2000
Qualitative Chemical
Characterization and
Documentation of
Qualitative
Pharmaceutical
Equivalence
------------------------------------------------------------------------
BACPAC I: Intermediates in February Chemistry Do. http://
Drug Substance Synthesis: 16, www.fda.g
Bulk Actives Postapproval 2001 ov/cder/
Changes: Chemistry, guidance/
Manufacturing, and index.htm
Controls Documentation
------------------------------------------------------------------------
Changes to an Approved July 24, Do. Do. Do.
Application for Specified 1997
Biotechnology and
Specified Synthetic
Biological Products
------------------------------------------------------------------------
Changes to an Approved NDA April Do. Do. Do.
or ANDA 2004
------------------------------------------------------------------------
Changes to an Approved NDA January Do. Do. Do.
or ANDA: Questions and 22,
Answers 2001
------------------------------------------------------------------------
Container Closure Systems May 1999 Do. Do. Do.
for Packaging Human Drugs
and Biologics
------------------------------------------------------------------------
[[Page 842]]
Demonstration of April Do. Do. Do.
Comparability of Human 1996
Biological Products,
Including Therapeutic
Biotechnology-Derived
Products
------------------------------------------------------------------------
Development of New May 1, Do. Do. Do.
Stereoisomeric Drugs 1992
------------------------------------------------------------------------
Drug Master Files Septembe Do. Do. Do.
r 1,
1989
------------------------------------------------------------------------
Drug Master Files for Bulk November Do. Do. Do.
Antibiotic Drug 29,
Substances 1999
------------------------------------------------------------------------
Environmental Assessment July 27, Do. Do. Do.
of Human Drug and 1998
Biologics Applications
------------------------------------------------------------------------
Format and Content for the Septembe Do. Do. Do.
CMC Section of an Annual r 1,
Report 1994
------------------------------------------------------------------------
Format and Content of the February Do. Do. Do.
Chemistry, Manufacturing, 1, 1987
and Controls Section of
an Application
------------------------------------------------------------------------
Format and Content of the February Do. Do. Do.
Microbiology Section of 1, 1987
an Application
------------------------------------------------------------------------
IND Meetings for Human May 25, Do. Do. Do.
Drugs and Biologics; 2001
Chemistry, Manufacturing,
and Controls Information
------------------------------------------------------------------------
INDs for Phase 2 and 3 May 20, Do. Do. Do.
Studies; Chemistry, 2003
Manufacturing, and
Controls Information
------------------------------------------------------------------------
Monoclonal Antibodies Used March Do. Do. Do.
as Reagents in Drug 29,
Manufacturing 2001
------------------------------------------------------------------------
Nasal Spray and Inhalation July 5, Do. Do. Do.
Solution, Suspension, and 2002
Spray Drug Products--
Chemistry, Manufacturing,
and Controls
Documentation
------------------------------------------------------------------------
NDAs: Impurities in Drug February Do. Do. Do.
Substances 25,
2000
------------------------------------------------------------------------
PAC-ALTS: Postapproval April Do. Do. Do.
Changes--Analytical 28,
Testing Laboratory Sites 1998
------------------------------------------------------------------------
Reviewer Guidance: November Do. Do. Do.
Validation of 1994
Chromatographic Methods
------------------------------------------------------------------------
Submission Documentation November Do. Do. Do.
for Sterilization Process 1, 1994
Validation in
Applications for Human
and Veterinary Drug
Products
------------------------------------------------------------------------
Submission of Chemistry, November Do. Do. Do.
Manufacturing, and 1994
Controls Information for
Synthetic Peptide
Substances
------------------------------------------------------------------------
Submitting Documentation February Do. Do. Do.
for the Manufacturing of, 1, 1987
and Controls for, Drug
Products
------------------------------------------------------------------------
Submitting Documentation February Do. Do. Do.
for the Stability of 1, 1987
Human Drugs and Biologics
------------------------------------------------------------------------
Submitting Samples and February Do. Do. Do.
Analytical Data for 1987
Methods Validation
------------------------------------------------------------------------
Submitting Supporting February Do. Do. N/A
Documentation in Drug 1, 1987
Applications for the
Manufacture of Drug
Products
------------------------------------------------------------------------
Submitting Supporting February Do. Do. http://
Documentation in Drug 1987 www.fda.g
Applications for the ov/cder/
Manufacture of Drug guidance/
Substances index.htm
------------------------------------------------------------------------
[[Page 843]]
SUPAC IR--Immediate- November Do. Do. Do.
Release Solid Oral Dosage 1995
Forms: Scale-Up and
Postapproval Changes:
Chemistry, Manufacturing
and Controls, In Vitro
Dissolution Testing, and
In Vivo Bioequivalence
Documentation
------------------------------------------------------------------------
SUPAC IR/MR: Immediate January Do. Do. Do.
Release and Modified 1999
Release Solid Oral Dosage
Forms Manufacturing
Equipment Addendum
------------------------------------------------------------------------
SUPAC-IR Questions and February Do. Do. Do.
Answers About SUPAC-IR 18,
Guidance 1997
------------------------------------------------------------------------
SUPAC-MR: Modified Release October Do. Do. Do.
Solid Oral Dosage Forms 6, 1997
Scale-Up and Postapproval
Changes: Chemistry,
Manufacturing, and
Controls; In Vitro
Dissolution Testing and
In Vivo Bioequivalence
Documentation
------------------------------------------------------------------------
SUPAC-SS--Nonsterile May 1997 Do. Do. Do.
Semisolid Dosage Forms
Scale-Up and Postapproval
Changes: Chemistry,
Manufacturing, and
Controls; In Vitro
Release Testing and In
Vivo Bioequivalence
Documentation
------------------------------------------------------------------------
The Sourcing and December Do. Do. Do.
Processing of Gelatin to 20,
Reduce the Potential Risk 2000
Posed by Bovine
Spongiform Encephalopathy
(BSE)
------------------------------------------------------------------------
Analytical Procedures and August Chemistry Do. Do.
Methods Validation: 30, draft
Chemistry, Manufacturing, 2000
and Controls
Documentation
------------------------------------------------------------------------
Botanical Drug Products June 9, Do. Do. Do.
2004
------------------------------------------------------------------------
Comparability Protocols-- February Do. Do. Do.
Chemistry, Manufacturing, 25,
and Controls Information 2003
------------------------------------------------------------------------
Drug Product: Chemistry, January Do. Do. Do.
Manufacturing, and 28,
Controls Information 2003
------------------------------------------------------------------------
Drug Substance: Chemistry, January Do. Do. Do.
Manufacturing, and 7, 2004
Controls Information
------------------------------------------------------------------------
Drugs, Biologics, and Septembe Do. Do. Do.
Medical Devices Derived r 2002
From Bioengineered Plants
for Use in Humans and
Animals
------------------------------------------------------------------------
Interpreting Sameness of July Do. .......... Do.
Monoclonal Antibody 1999
Products Under the Orphan
Drug Regulations
------------------------------------------------------------------------
Liposome Drug Products: August Do. Do. Do.
Chemistry, Manufacturing, 2002
and Controls; Human
Pharmacokinetics and
Bioavailability; and
Labeling Documentation
------------------------------------------------------------------------
Metered Dose Inhaler (MDI) November Do. Do. Do.
and Dry Powder Inhaler 19,
(DPI) Drug Products; 1998
Chemistry, Manufacturing,
and Controls
Documentation
------------------------------------------------------------------------
Stability Testing of Drug June 8, Do. Do. Do.
Substances and Drug 1998
Products
------------------------------------------------------------------------
Submitting Supporting November Do. Do. N/A
Chemistry Documentation 1, 1991
in Radiopharmaceutical
Drug Applications
------------------------------------------------------------------------
SUPAC-SS: Nonsterile January Do. Do. http://
Semisolid Dosage Forms 5, 1999 www.fda.g
Manufacturing Equipment ov/cder/
Addendum guidance/
index.htm
------------------------------------------------------------------------
[[Page 844]]
Antiretroviral Drugs Using October Clinical Do. Do.
Plasma HIV RNA 2002 antimicro
Measurements--Clinical bial
Considerations for
Accelerated and
Traditional Approval
------------------------------------------------------------------------
Clinical Development and October Do. Do. Do.
Labeling of Anti- 26,
Infective Drug Products 1992
------------------------------------------------------------------------
Clinical Evaluation of Septembe Do. Do. Do.
Anti-Infective Drugs r 1,
(Systemic) 1977
------------------------------------------------------------------------
Preclinical Development of November Do. Do. Do.
Antiviral Drugs 1990
------------------------------------------------------------------------
Acute Bacterial July 22, Clinical Do. Do.
Exacerbation of Chronic 1998 antimicro
Bronchitis; Developing bial
Antimicrobial Drugs for draft
Treatment
------------------------------------------------------------------------
Acute Bacterial July 22, Do. Do. Do.
Meningitis; Developing 1998
Antimicrobial Drugs for
Treatment
------------------------------------------------------------------------
Acute Bacterial Sinusitis; July 22, Do. Do. Do.
Developing Antimicrobial 1998
Drugs for Treatment
------------------------------------------------------------------------
Acute or Chronic Bacterial July 22, Do. Do. Do.
Prostatitis; Developing 1998
Antimicrobial Drugs for
Treatment
------------------------------------------------------------------------
Acute Otitis Media; July 22, Do. Do. Do.
Developing Antimicrobial 1998
Drugs for Treatment
------------------------------------------------------------------------
Bacterial Vaginosis; July 22, Do. Do. Do.
Developing Antimicrobial 1998
Drugs for Treatment
------------------------------------------------------------------------
Catheter-Related October Do. Do. Do.
Bloodstream Infections-- 18,
Developing Antimicrobial 1999
Drugs for Treatment
------------------------------------------------------------------------
Community Acquired July 22, Do. Do. Do.
Pneumonia; Developing 1998
Antimicrobial Drugs for
Treatment
------------------------------------------------------------------------
Complicated Urinary Tract July 22, Do. Do. Do.
Infections and 1998
Pylonephritis--Developing
Antimicrobial Drugs for
Treatment
------------------------------------------------------------------------
Developing Antimicrobial July 22, Do. Do. Do.
Drugs--General 1998
Considerations for
Clinical Trials
------------------------------------------------------------------------
Developing Drugs to Treat March Do. Do. Do.
Inhalational Anthrax 18,
(Post-Exposure) 2002
------------------------------------------------------------------------
Empiric Therapy of Febrile July 22, Do. Do. Do.
Neutropenia--Developing 1998
Antimicrobial Drugs for
Treatment
------------------------------------------------------------------------
Evaluating Clinical February Do. Do. Do.
Studies of Antimicrobials 1997
in the Division of Anti-
Infective Drug Products
------------------------------------------------------------------------
Lyme Disease--Developing July 22, Do. Do. Do.
Antimicrobial Drugs for 1998
Treatment
------------------------------------------------------------------------
Nosocomial Pneumonia-- July 22, Do. Do. Do.
Developing Antimicrobial 1998
Drugs for Treatment
------------------------------------------------------------------------
Secondary Bacterial July 22, Do. Do. Do.
Infections of Acute 1998
Bronchitis--Developing
Antimicrobial Drugs for
Treatment
------------------------------------------------------------------------
Streptococcal Pharyngitis July 22, Do. Do. Do.
and Tonsillitis-- 1998
Developing Antimicrobial
Drugs for Treatment
------------------------------------------------------------------------
Uncomplicated and July 22, Do. Do. Do.
Complicated Skin and Skin 1998
Structure Infections--
Developing Antimicrobial
Drugs for Treatment
------------------------------------------------------------------------
[[Page 845]]
Uncomplicated Gonorrhea-- July 22, Do. Do. Do.
Developing Antimicrobial 1998
Drugs for Treatment
------------------------------------------------------------------------
Uncomplicated Urinary July 22, Do. Do. Do.
Tract Infections-- 1998
Developing Antimicrobial
Drugs for Treatment
------------------------------------------------------------------------
Vaccinia Virus--Developing March Do. Do. Do.
Drugs to Mitigate 2004
Complications From
Smallpox Vaccination
------------------------------------------------------------------------
Vuvlovaginal Candidiasis-- July 22, Do. Do. Do.
Developing Antimicrobial 1998
Drugs for Treatment
------------------------------------------------------------------------
Acceptance of Foreign March Clinical Do. Do.
Clinical Studies 2001 medical
------------------------------------------------------------------------
Calcium DTPA and Zinc DTPA August Do. Do. Do.
Drug Products--Submitting 2004
a New Drug Application
------------------------------------------------------------------------
Cancer Drug and Biological October Do. Do. Do.
Products--Clinical Data 2001
in Marketing Applications
------------------------------------------------------------------------
Clinical Development February Do. Do. Do.
Programs for Drugs, 1999
Devices, and Biological
Products for the
Treatment of Rheumatoid
Arthritis (RA)
------------------------------------------------------------------------
Clinical Development Septembe Do. Do. Do.
Programs for MDI and DPI r 19,
Drug Products 1994
------------------------------------------------------------------------
Clinical Evaluation of April Do. Do. Do.
Anti-Inflammatory and 1988
Antirheumatic Drugs
(adults and children)
------------------------------------------------------------------------
Clinical Evaluation of Septembe Do. Do. Do.
Antianxiety Drugs r 1,
1977
------------------------------------------------------------------------
Clinical Evaluation of Septembe Do. Do. Do.
Antidepressant Drugs r 1,
1977
------------------------------------------------------------------------
Clinical Evaluation of January Do. Do. Do.
Antiepileptic Drugs 1, 1981
(adults and children)
------------------------------------------------------------------------
Clinical Evaluation of May 1, Do. Do. Do.
General Anesthetics 1982
------------------------------------------------------------------------
Clinical Evaluation of Septembe Do. Do. Do.
Hypnotic Drugs r 1,
1977
------------------------------------------------------------------------
Clinical Evaluation of May 1982 Do. Do. Do.
Local Anesthetics
------------------------------------------------------------------------
Clinical Evaluation of July Do. Do. Do.
Psychoactive Drugs in 1979
Infants and Children
------------------------------------------------------------------------
Content and Format for May 1996 Do. Do. Do.
Pediatric Use Supplements
------------------------------------------------------------------------
Content and Format of November Do. Do. Do.
Investigational New Drug 1995
Applications (INDs) for
Phase 1 Studies of Drugs,
Including Well-
Characterized,
Therapeutic,
Biotechnology-Derived
Products
------------------------------------------------------------------------
Establishing Pregnancy August Do. Do. Do.
Exposure Registries 2002
------------------------------------------------------------------------
FDA Approval of New Cancer February Do. Do. Do.
Treatment Uses for 2, 1999
Marketed Drug and
Biological Products
------------------------------------------------------------------------
FDA Requirements for January Do. Do. Do.
Approval of Drugs to 1991
Treat Non-Small Cell Lung
Cancer
------------------------------------------------------------------------
Format and Content of the July 1, Do. Do. Do.
Clinical and Statistical 1988
Sections of an
Application
------------------------------------------------------------------------
Format and Content of the February Do. Do. Do.
Summary for New Drug and 1, 1987
Antibiotic Applications
------------------------------------------------------------------------
Formatting, Assembling and February Do. Do. Do.
Submitting New Drug and 1, 1987
Antiobiotic Applications
------------------------------------------------------------------------
[[Page 846]]
General Considerations for December Do. Do. Do.
the Clinical Evaluation 1, 1978
of Drugs
------------------------------------------------------------------------
General Considerations for Septembe Do. Do. Do.
the Clinical Evaluation r 1,
of Drugs in Infants and 1977
Children
------------------------------------------------------------------------
Guidance for the April Do. Do. Do.
Development of Vaginal 1995
Contraceptive Drugs (NDA)
------------------------------------------------------------------------
IND Exemptions for Studies January Do. Do. Do.
of Lawfully Marketed Drug 15,
or Biological Products 2004
for the Treatment of
Cancer
------------------------------------------------------------------------
Integration of Dose- March Do. Do. Do.
Counting Mechanisms Into 2003
MDI Drug Products
------------------------------------------------------------------------
Levothyroxine Sodium March 8, Do. Do. Do.
Tablets--In Vivo 2001
Pharmacokinetic and
Bioavailability Studies
and In Vitro Dissolution
Testing
------------------------------------------------------------------------
Oncologic Drugs Advisory April Do. Do. Do.
Committee Discussion on 19,
FDA Requirements for 1988
Approval of New Drugs for
Treatment of Colon and
Rectal Cancer
------------------------------------------------------------------------
Oncologic Drugs Advisory April Do. Do. Do.
Committee Discussion on 1988
FDA Requirements for
Approval of New Drugs for
Treatment of Ovarian
Cancer
------------------------------------------------------------------------
Postmarketing Adverse August Do. Do. Do.
Experience Reporting for 27,
Human Drug and Licensed 1997
Biological Products:
Clarification of What to
Report
------------------------------------------------------------------------
Postmarketing Reporting of March 1, Do. Do. Do.
Adverse Drug Experiences 1992
------------------------------------------------------------------------
Preclinical Development of Septembe Do. Do. Do.
Immunomodulatory Drugs r 1992
for Treatment of HIV
Infection and Associated
Disorders
------------------------------------------------------------------------
Preparation of November Do. Do. Do.
Investigational New Drug 1, 1992
Products (Human and
Animal)
------------------------------------------------------------------------
Providing Clinical May 1998 Do. Do. Do.
Evidence of Effectiveness
for Human Drug and
Biological Products
------------------------------------------------------------------------
Prussian Blue Drug February Do. Do. Do.
Products--Submitting a 4, 2003
New Drug Application
------------------------------------------------------------------------
Study and Evaluation of July 22, Do. Do. Do.
Gender Differences in the 1993
Clinical Evaluation of
Drugs
------------------------------------------------------------------------
Study of Drugs Likely to November Do. Do. Do.
be Used in the Elderly 1, 1989
------------------------------------------------------------------------
Submission of Abbreviated Septembe Do. Do. Do.
Reports and Synopses in r 13,
Support of Marketing 1999
Applications
------------------------------------------------------------------------
Abuse Liability Assessment July 1, Clinical Do. N/A
1990 medical
draft
------------------------------------------------------------------------
Allergic Rhinitis: June 21, Do. Do. http://
Clinical Development 2000 www.fda.g
Programs for Drug ov/cder/
Products guidance/
index.htm
--------------------------------------
------------------------------------------------------------------------
Chronic Cutaneous Ulcer June 28, Do. Do. Do.
and Burn Wounds-- 2000
Developing Products for
Treatment
------------------------------------------------------------------------
[[Page 847]]
Clinical Development July Do. Do. Do.
Programs for Drugs, 1999
Devices, and Biological
Products Intended for the
Treatment of
Osteoarthritis (OA)
------------------------------------------------------------------------
Clinical Evaluation of January Do. Do. N/A
Anti-Anginal Drugs 1, 1989
------------------------------------------------------------------------
Clinical Evaluation of July 1, Do. Do. Do.
Anti-Arrhythmic Drugs 1985
------------------------------------------------------------------------
Clinical Evaluation of May 1, Do. Do. Do.
Antihypertensive Drugs 1988
------------------------------------------------------------------------
Clinical Evaluation of December Do. Do. Do.
Drugs for the Treatment 1, 1987
of Congestive Heart
Failure
------------------------------------------------------------------------
Clinical Evaluation of Septembe Do. Do. http://
Lipid-Altering Agents in r 1990 www.fda.g
Adults and Children