Drugs

Procedural

Below is a sortable table of Procedural Guidances

CategoryTitleTypeDate
Procedural 180-Day Generic Drug Exclusivity Under the Hatch-Waxman Amendments to the Federal Food, Drug, and Cosmetic Act (PDF - 77KB) Final Guidance 06/01/98
Procedural Applications Covered by Section 505(b)(2) (PDF - 41KB) Draft Guidance 12/08/99
Procedural Certification Process of Designated Medical Gases (PDF - 279KB) Draft Guidance, Revised 11/24/15
Procedural Charging for Investigational Drugs Under an IND — Qs & As (PDF - 87KB) Final Guidance 06/02/16
Procedural Citizen Petitions and Petitions for Stay of Action Subject to Section 505(q) of the Federal Food, Drug, and Cosmetic Act (PDF - 136KB) Final Guidance 11/18/14
FDA/CBER - Draft Guidance for Industry: Complementary and Alternative Medicine Products and Their Regulation by the Food and Drug Administration Complementary and Alternative Medicine Products and their Regulation by the Food and Drug Administration Draft Guidance 12/01/06
CBER -Guidance for Industry: Cooperative Manufacturing Arrangements for Licensed Biologics Guidance for Industry: Cooperative Manufacturing Arrangements for Licensed Biologics Need to get correct link to http://www.fda.gov/cber/guidelines.htm & http://www.fda.gov/cber/guidelines.htm
Procedural Court Decisions, ANDA Approvals, and 180-Day Exclusivity Under the Hatch-Waxman Amendments to the Federal Food, Drug, and Cosmetic Act (PDF - 25KB) Final Guidance 03/27/00
Procedural Dear Health Care Provider Letters:Improving Communication of Important Safety Information (PDF - 128KB) Final Guidance 01/22/14
Procedural Disclosure of Materials Provided to Advisory Committees in Connection with Open Advisory Committee Meetings Convened by the Center for Drug Evaluation and Research Beginning on January 1, 2000 (PDF - 10KB) Final Guidance 11/01/99
Procedural Drug Products Containing Ensulizole, Hypromellose, Meradimate, Octinoxate, and Octisalate — Labeling Enforcement Policy (PDF - 159KB) Final Guidance 06/03/03
ProceduralGuidance - Emergency Use Authorization of Medical Products Emergency Use Authorization of Medical Products and Related Authorities Draft Guidance, published April 2016 04/01/16
Procedural End-of-Phase 2A Meetings (PDF - 163KB) Final Guidance 09/18/09
Procedural Enforcement Policy -- OTC Sunscreen Drug Products Marketed Without an Approved Application (PDF - 83KB) Draft Guidance 06/14/11
Procedural Expedited Programs for Serious Conditions––Drugs and Biologics (PDF - 276KB) Final Guidance 05/30/14
Procedural Expanded Access to Investigational Drugs for Treatment Use — Qs & As (PDF - 180KB) Final Guidance 06/02/16
Appendix 4 (PDF - 3.9MB)
Guidance for Industry - FDA Export Certificates FDA Export Certificates Final Guidance 07/12/04
Procedural FDA Oversight of PET Drug Products -- Questions and Answers (PDF - 499KB) Final Guidance 12/03/12
Procedural Fixed Dose Combinations, Co-Packaged Drug Products, and Single-Entity Versions of Previously Approved Antiretrovirals for the Treatment of HIV (PDF - 343KB) Final Guidance 10/17/06
Procedural Formal Dispute Resolution: Appeals Above the Division Level_Final (PDF - 96KB) Final Guidance 02/01/00
Procedural Formal Dispute Resolution: Appeals Above the Division Level _Draft (PDF - 281KB) Draft Guidance 09/08/15
Biosimilarity; Procedural Formal Meetings Between the FDA and Biosimilar Biological Product Sponsors or Applicants (PDF - 306KB) Final Guidance 11/17/15
Procedural Formal Meetings Between the FDA and Sponsors or Applicants This final guidance is updated by the draft guidance posted 3/10/15 (PDF - 69KB) Final Guidance Rev. 1 05/19/09
Procedural Guidance for Industry - Good Reprint Practices for the Distribution of Medical Journal Articles and Medical or Scientific Reference Publications on Unapproved New Uses of Approved Drugs and Approved or Cleared Medical Devices Good Reprint Practices for the Distribution of Medical Journal Articles and Medical or Scientific Reference Publications on Unapproved New Uses of Approved Drugs and Approved or Cleared Medical Devices Final Guidance 01/01/09
Procedural Good Review Management Principles and Practices for PDUFA Products (PDF - 683KB) Final Guidance 03/01/05
Procedural Guidance for FDA Staff: The Leveraging Handbook; An Agency Resource for Effective Collaborations. Final Guidance 06/01/03
Procedural Guidance for Clinical Investigators, Sponsors, and IRBs: Adverse Event Reporting to IRBs — Improving Human Subject Protection (PDF - 61KB) Final Guidance 01/14/09
Information Sheet - Guidance for Institutional Review Boards and Clinical Investigators (Data Retention When Subjects Withdraw from FDA-Regulated Clinical Trials) Data Retention When Subjects Withdraw from FDA-Regulated Clinical Trials (PDF - 75KB) 10/01/08
Procedural How to Comply with the Pediatric Research Equity Act (PDF - 116KB) Draft Guidance 09/07/05
Procedual Implementation of Section 120 of the Food and Drug Administration Modernization Act of 1997-Advisory Committees (PDF - 62KB) Final Guidance 10/01/98
Procedural Implementation of Section 126 of the Food and Drug Administration Modernization Act of 1997 - Elimination of Certain Labeling Requirements (PDF - 979KB) Final Guidance 07/01/98
Guidance for Industry - Independent Consultants for Biotechnology Clinical Trial Protocols Independent Consultants for Biotechnology Clinical Trial Protocols Final Guidance 08/01/04
Modernization Act; Procedural Information Program on Clinical Trials for Serious or Life-Threatening Diseases and Conditions-Draft Guidance (PDF - 40KB) Draft Guidance 01/01/04
Modernization Act; Procedural Information Program on Clinical Trials for Serious or Life-Threatening Diseases and Conditions. (PDF - 34KB) Final Guidance 03/01/02
User Fees Information Request and Discipline Review Letters Under the Prescription Drug User Fee Act (PDF - 27KB) Final Guidance 11/01/01
Financial Disclosure by Clinical Investigators Financial Disclosure by Clinical Investigators (PDF - 165KB) 02/01/13
Information Sheet Guidance for Sponsors, Clinical Investigators, and IRBs on FDA Form 1572, Statement of Investigator Frequently Asked Questions – Statement of Investigator (Form FDA 1572) - Information Sheet (PDF - 105KB) Final Guidance 05/01/10
Procedural Integrated Summaries of Effectiveness and Safety: Location Within the Common Technical Document (PDF - 98KB) Final Guidance 04/20/09
Procedural Integrated Summary of Effectiveness (PDF - 274KB) Final Guidance 10/07/15
Procedural Investigator Responsibilities — Protecting the Rights, Safety, and Welfare of Study Subjects (PDF - 163KB) Final Guidance 10/23/09
Procedural Levothyroxine Sodium Products Enforcement of August 14, 2001 Compliance Date and Submission of New Applications (PDF - 24KB) Final Guidance 07/01/01
Drug Safety Medication Guides — Adding a Toll-Free Number for Reporting Adverse Events (PDF - 67KB) Final Guidance 06/08/09
Procedural Oversight of Clinical Investigations — A Risk-Based Approach to Monitoring (PDF - 174KB) Final Guidance 08/06/13
Procedural Pediatric Study Plans: Content of and Process for Submitting Initial Pediatric Study Plans and Amended Pediatric Study Plans (PDF - 408KB) Draft Guidance 03/08/16
Procedural; Modernization Act PET Drug Applications - Content and Format for NDAs and ANDAs_2011 (PDF - 429KB) Final Guidance 08/31/11
Procedural; Modernization Act PET Drug Applications - Content and Format for NDAs and ANDAs: Attachment I: Sample formats for chemistry, manufacturing, and controls (CMC) sections_2011 (PDF - 614KB) Final Guidance 08/31/11
Procedural; Modernization Act Sample formats for Form FDA 356h_2011 (PDF - 601KB) Draft Guidance 02/02/11
Positron Emission Tomography (PET) Drug SPL
Procedural Pharmacogenomic Data Submissions (PDF - 307KB) Final Guidance 03/01/05
Procedural Pharmacogenomic Data Submissions; Examples of Voluntary Submissions or Submissions Required Under 21 CFR 312, 314, or 601 (PDF - 63KB) Final Guidance 03/01/05
Procedural Pharmacogenomic Data Submissions — Companion Guidance (PDF - 211KB) Draft Guidance 08/28/07
Procedural Planning for the Effects of High Absenteeism to Ensure Availability of Medically Necessary Drug Products (PDF - 82KB) Final Guidance 03/14/11
Procedural Postmarketing Safety Reporting for Human Drug and Biological Products Including Vaccines (PDF - 375KB) Draft Guidance 03/12/01
Procedural Potassium Iodide as a Thyroid Blocking Agent in Radiation Emergencies (PDF - 40KB) Final Guidance 12/10/01
Procedural (Potassium Iodide) KI in Radiation Emergencies-Questions and Answers (PDF - 161KB) Final Guidance 12/23/02
Procedural Potassium Iodide Tablets - Shelf Life Extension (PDF - 191KB) Final Guidance 03/08/04
Guidance for the Public, FDA Advisory Committee Members, and FDA Staff on Procedures for Determining Conflict of Interest and Eligibility for Participation in FDA Advisory Committees (PDF) Procedures for Determining Conflict of Interest and Eligibility for Participation in FDA Advisory Committees (PDF - 106KB) 08/01/08
Guidance for Clinical Investigators, Institutional Review Boards and Sponsors - Process for Handling Referrals to FDA Under 21 CFR 50.54 - Additional Safeguards for Children in Clinical Investigations (PDF) Guidance for Clinical Investigators, Institutional Review Boards and Sponsors - Process for Handling Referrals to FDA Under 21 CFR 50.54 - Additional Safeguards for Children in Clinical Investigations (PDF) (PDF - 116KB) 12/01/06
Repeal of Section 507 of the Federal Food, Drug and Cosmetic Act  (PDF - 85KB)
Modernization Act Reports on the Status of Postmarketing Study Commitments — Implementation of Section 130 of the Food and Drug Administration Modernization Act of 1997 (PDF - 456KB) Final Guidance 02/15/06
Procedural Special Protocol Assessment (PDF - 61KB) Final Guidance 05/01/02
Standards for Prompt Review of Efficacy Supplements  (PDF - 76KB)
Guidance for Industry - Standards for Securing the Drug Supply Chain - Standardized Numerical Identification for Prescription Drug Packages Standards for Securing the Drug Supply Chain - Standardized Numerical Identification for Prescription Drug Packages 03/01/10
Procedural Submitting and Reviewing Complete Responses to Clinical Holds (Revised) (PDF - 26KB) Final Guidance 10/01/00
Procedural Submitting Debarment Certification Statements (PDF - 144KB) Draft Guidance 10/02/98
Procedural Submitting Marketing Applications According to the ICH/CTD Format: General Considerations 2001 (PDF - 50KB) Draft Guidance 09/05/01
Procedural Target Product Profile -- A Strategic Development Process Tool (PDF - 454KB) Draft Guidance 03/30/07
Draft Guidance for Industry and FDA Staff: Technical Considerations for Pen, Jet, and Related Injectors Intended for Use with Drugs and Biological Products Technical Considerations for Pen, Jet, and Related Injectors Intended for Use with Drugs and Biological Products (PDF - 153KB) 06/06/13
Guidance for Industry and Clinical Investigators - The Use of Clinical Holds Following Clinical Investigator Misconduct The Use of Clinical Holds Following Clinical Investigator Misconduct (PDF - 37KB) 09/01/04
Procedural "Toll-Free Number Labeling and Related Requirements for Over-the-Counter and Prescription Drugs Marketed With Approved Applications" (PDF - 119KB) Final Guidance 06/14/12
Procedural Tropical Disease Priority Review Vouchers (PDF - 112KB) Draft Guidance 10/20/08
Procedural Considerations for Use of Histopathology and Its Associated Methodologies to Support Biomarker Qualification Guidance for Industry (PDF - 126KB) Final Guidance 05/13/16
Procedural Useful Written Consumer Medication Information (CMI) (PDF - 278KB) Final Guidance 07/17/06
Procedural Using a Centralized IRB Review Process in Multicenter Clinical Trials (PDF - 87KB) Final Guidance 03/15/06
Procedural Waiver of IRB Requirements for Drug and Biological Product Studies (PDF - 35KB) Final Guidance 01/01/06
Procedural Women and Minorities Guidance Requirements (PDF - 30KB) Final Guidance 07/20/98
Procedural Responding to Unsolicited Requests for Off-Label Information About Prescription Drugs and Medical Devices (PDF - 302KB) Draft Guidance 12/27/11
Modernization Act; Procedural National Uniformity for Nonpresciption Drugs - Ingredient Listing for OTC Drugs (PDF - 74KB) Final Guidance 04/01/98
Guidance for IRBs, Clinical Investigators, and Sponsors: IRB Continuing Review After Clinical Investigation Approval IRB Continuing Review After Clinical Investigation Approval (PDF - 145KB) 02/01/12
Procedural Electronic Source Data in Clinical Investigations (PDF - 190KB) Final Guidance 09/17/13
Procedural Pre-Launch Activities Importation Requests (PLAIR) (PDF - 180KB) Draft Guidance 07/24/13
Procedural Specification of the Unique Facility Identifier (UFI) System for Drug Establishment Registration (PDF - 183KB) Draft Guidance 09/04/13
Procedural /Clinical/Medical Qualification Process for Drug Development Tools (PDF - 499KB) Final Guidance 01/06/14
Clinical/Medical/Procedural Qualification Process for Drug Development Tools: (Attachment) Qualification of Exacerbations of Chronic Pulmonary Disease Tool for Measurement of Symptoms of Acute Bacterial Exacerbation of Chronic Bronchitis in Patients With Chronic Obstructive Pulmonary Disease (PDF - 80KB) Draft Guidance 01/09/14
Procedural Distributing Scientific and Medical Publications on Unapproved New Uses — Recommended Practices - Revised Guidance (PDF - 150KB) Draft Guidance - Revised 02/28/14
Procedural Distributing Scientific and Medical Publications on Risk Information for Approved Prescription Drugs and Biological Products—Recommended Practices (PDF - 95KB) Draft Guidance 06/06/14
Procedural Drug Supply Chain Security Act Implementation: Identification of Suspect Product and Notification (PDF - 1.3MB) Draft Guidance 06/10/14
Procedural; Biosimilarity Reference Product Exclusivity for Biological Products Filed Under (PDF - 99KB) Draft Guidance 08/04/14
Procedural FDA’s guidance on uniform national policy (Section 585 of the FD&C Act) (PDF - 155KB) Draft Guidance 10/07/14
Procedural Critical Path Innovation Meetings (PDF - 68KB) Final Guidance 03/30/15
Procedural New Chemical Entity Exclusivity Determinations for Certain Fixed-Combination Drug Products (PDF - 351KB) Final Guidance 10/10/14
Procedural Specification of the Unique Facility Identifier (UFI) System for Drug Establishment (PDF - 61KB) Final Guidance 11/05/14
Procedural Guidance for FDA Staff: The Leveraging Handbook; An Agency Resource for Effective Collaborations. Final Guidance 06/01/03
Procedural DSCSA Standards for the Interoperable Exchange of Information for Tracing of Certain Human, Finished, Prescription Drugs: How to Exchange Product Tracing Information (PDF - 85KB) Draft Guidance 11/26/14
Procedural DSCSA Implementation: Annual Reporting by Prescription Drug Wholesale Distributors and Third-Party Logistics Providers (PDF - 94KB) Draft Guidance 12/08/14
Procedural DSCSA Implementation: Product Tracing Requirements — Compliance Policy (PDF - 56KB) Final Guidance 12/23/14
Procedural Individual Patient Expanded Access Applications: Form FDA 3926 (PDF - 88KB) Final Guidance 06/02/16
Procedural Use of Electronic Informed Consent in Clinical Investigations – Questions and Answers (PDF - 110KB) Draft Guidance 03/06/15
Procedural Formal Meetings Between the FDA and Sponsors or Applicants of PDUFA Products This draft guidance updates the Final guidance (PDF - 336KB) Draft Guidance 03/10/15
Procedural Investigational New Drug Applications Prepared and Submitted by Sponsor-Investigators (PDF - 431KB) Draft Guidance 05/14/15
Compounding/Procedural Guidance For Entities Considering Whether to Register As Outsourcing Facilities Under Section 503B of the Federal Food, Drug, and Cosmetic Act (PDF - 74KB) Final Guidance 08/11/15
Compounding/Procedural Registration for Human Drug Compounding Outsourcing Facilities Under Section 503B of the Federal Food, Drug, and Cosmetic Act (PDF - 71KB) Final Guidance 11/21/14
Compounding/Procedural Electronic Drug Product Reporting for Human Drug Compounding Outsourcing Facilities Under Section 503B of the Federal Food, Drug, and Cosmetic Act.” (PDF - 70KB) Draft 11/21/14
Procedural DSCSA Implementation: Product Tracing Requirements for Dispensers — Compliance Policy (Revised) Guidance for Industry (PDF - 55KB) Final Guidance 10/28/15
Pharmaceutical Quality/CMC Guidance for Industry - Container and Closure System Integrity Testing in Lieu of Sterility Testing as a Component of the Stability Protocol for Sterile Products (PDF) (PDF - 64KB) Final Guidance 02/01/08
Compounding; Procedural Pharmacy Compounding of Human Drug Products Under Section 503A of the Federal Food, Drug, and Cosmetic Act Guidance (PDF - 85KB) Final Guidance 06/09/16
Compounding; Procedural Interim Policy on Compounding Using Bulk Drug Substances Under Section 503A of the Federal Food, Drug, and Cosmetic Act Guidance for Industry (PDF - 127KB) Final Guidance 06/09/16
Compounding; Procedural Interim Policy on Compounding Using Bulk Drug Substances Under Section 503B of the Federal Food, Drug, and Cosmetic Act (PDF - 227KB) Final Guidance 06/09/16
Procedural Best Practices for Communication Between IND Sponsors and FDA During Drug Development (PDF - 253KB) Draft Guidance 12/04/15
Procedural Requirements for Transactions with First Responders under Section 582 of the Federal Food, Drug, and Cosmetic Act— Compliance Policy Guidance for Industry (PDF - 88KB) Final guidance 02/29/16
Procedural Implementation of the “Deemed to be a License” Provision of the Biologics Price Competition and Innovation Act of 2009 (Corrected Appendix posted on 3/21/16) (PDF - 138KB) Draft Guidance (corrected Appendix posted on 3/21/16) 03/11/16
Procedural Special Protocol Assessment Guidance for Industry (PDF - 640KB) Draft Guidance 05/03/16
Procedural Use of Electronic Health Record Data in Clinical Investigations Guidance for Industry (PDF - 247KB) Draft Guidance 05/16/16

Page Last Updated: 07/15/2016
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