| Title and Format |
Type |
Issue Date |
| 180-Day Generic Drug Exclusivity Under the Hatch-Waxman Amendments to the Federal Food, Drug, and Cosmetic Act |
Final |
6/1998 |
| Applications Covered by Section 505(b)(2) |
Draft |
10/1999 |
| Citizen Petitions and Petitions for Stay of Action Subject to Section 505(q) of the Federal Food, Drug, and Cosmetic Act |
Draft |
1/16/2009 |
| Complementary and Alternative Medicine Products and Their Regulation by the Food and Drug Administation |
Draft
|
12/2006 |
| Container and Closure System Integrity Testing in Lieu of Sterility Testing as a Component of the Stability Protocol for Sterile Products |
Final |
2/22/2008 |
| Continuous Marketing Applications: Pilot 1 – Reviewable Units for Fast Track Products Under PDUFA |
Final |
Posted 10/1/2003 |
| Continuous Marketing Applications: Pilot 2 – Scientific Feedback and Interactions During Development of Fast Track Products Under PDUFA
|
Final |
Posted 10/1/2003 |
| Cooperative Manufacturing Arrangements for Licensed Biologics |
Final |
12/3/2008 |
| Court Decisions, ANDA Approvals, and 180-Day Exclusivity Under the Hatch-Waxman Amendments to the Federal Food, Drug, and Cosmetic Act |
Final |
Posted 3/27/2000 |
| Disclosing Information Provided to Advisory Committees in Connection with Open Advisory Committee Meetings Related to the Testing or Approval of New Drugs and Convened by the Center for Drug Evaluation and Research, Beginning on January 1, 2000 |
Draft |
12/1999 |
| Disclosure of Conflicts of Interest for Special Government Employees Participating in FDA Product Specific Advisory Committees |
Draft |
2/14/2002 |
| 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 |
Final |
11/1999 |
| Drug Products Containing Ensulizole, Hypromellose, Meradimate, Octinoxate, and Octisalate — Labeling Enforcement Policy |
Final |
6/3/2003 |
| Emergency Use Authorization of Medical Products; Availability |
Draft |
7/5/2005 |
| End-of-Phase 2A Meetings |
Final |
9/18/2009 |
| Enforcement Policy During Implementation of Section 503A of the Federal Food, Drug, and Cosmetic Act |
Final |
11/1998 |
Fast Track Drug Development Programs - Designation, Development, and Application Review
Appendix 2 [Appendices are scanned copies, which will be replaced by final versions 11/18] (Issued 11/17/1998, Posted 11/17/1998) |
Final |
1/12/2006 |
| FDA Export Certificates |
Final |
7/2004 |
| Financial Disclosure by Clinical Investigators |
Final |
3/27/2001 |
| Fixed Dose Combinations, Co-Packaged Drug Products, and Single-Entity Versions of Previously Approved Antiretrovirals for the Treatment of HIV |
Final |
10/17/2006 |
| Formal Dispute Resolution: Appeals Above the Division Level |
Final
|
2/2000 |
| Formal Meetings Between the FDA and Sponsors or Applicants |
Final |
5/19/2009 |
| Forms for Registration of Producers of Drugs and Listing of Drugs in Commercial Distribution |
Draft |
5/14/2001 |
| 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 U.S. |
Final |
1/14/2009 |
| Good Review Management Principles and Practices for PDUFA Products |
Final |
3/2005 |
| Guidance for FDA Staff: The Leveraging Handbook; An Agency Resource for Effective Collaborations |
Final |
Revised 6/2003 |
| Guidance for Clinical Investigators, Sponsors, and IRBs Adverse Event Reporting to IRBs — Improving Human Subject Protection |
Final |
1/14/2009 |
| Guidance for Sponsors, Clinical Investigators, and IRBs; Data Retention When Subjects Withdraw From FDA-Regulated Clinical Trials; Availability |
Draft |
12/2/2008 |
| How to Comply with the Pediatric Research Equity Act |
Draft |
9/7/2005 |
| Implementation of Section 120 of the Food and Drug Administration Modernization Act of 1997-Advisory Committees |
Final |
10/1998 |
| Implementation of Section 126 of the Food and Drug Administration Modernization Act of 1997 - Elimination of Certain Labeling Requirements |
Final |
7/1998 |
| Independent Consultants for Biotechnology Clinical Trial Protocols |
Final |
8/18/2004 |
| Information Program on Clinical Trials for Serious or Life-Threatening Diseases and Conditions [Revision 1] |
Draft |
1/2004 |
| Information Program on Clinical Trials for Serious or Life-Threatening Diseases and Conditions |
Final |
3/2002 |
| Information Request and Discipline Review Letters Under the Prescription Drug User Fee Act |
Final |
11/2001 |
| Information Sheet Guidance for Sponsors, Clinical Investigators, and IRBs Frequently Asked Questions - Statement of Investigator (Form FDA 1572) |
Draft |
7/29/2008 |
| Integrated Summaries of Effectiveness and Safety: Location Within the Common Technical Document |
Final |
4/20/2009 |
| Integrated Summary of Effectiveness |
Draft |
7/26/2008 |
| Investigator Responsibilities — Protecting the Rights, Safety, and Welfare of Study Subjects (PDF - 163 KB) |
Final |
10/23/2009 |
| Levothyroxine Sodium Products Enforcement of August 14, 2001 Compliance Date and Submission of New Applications |
Final |
7/2001 |
| Medication Guides — Adding a Toll-Free Number for Reporting Adverse Events |
Final |
6/8/2009 |
| National Uniformity for Nonpresciption Drugs - Ingredient Listing for OTC Drugs |
Final |
4/1998 |
| PET Drug Applications - Content and Format for NDAs and ANDAs [(Issued , Posted 3/7/2000)
|
Draft |
3/7/2000 |
| Pharmacogenomic Data Submissions
|
Final |
3/2005 |
| Pharmacogenomic Data Submissions — Companion Guidance |
Draft |
8/28/2007 |
| Postmarketing Adverse Even Reporting for Medical products and Dietary Supplements During an Influenza Pandemic |
Draft |
12/15/2008 |
| Postmarketing Safety Reporting for Human Drug and Biological Products Including Vaccines |
Draft |
3/9/2001 |
| Potassium Iodide as a Thyroid Blocking Agent in Radiation Emergencies
|
Final |
12/10/2001
12/23/2002
|
| Potassium Iodide Tablets - Shelf Life Extension |
Final |
3/8/2004 |
| Procedures for Determining Conflict of Interest and Eligibility for Participation in FDA Advisory Committees |
Draft |
3/21/2007 |
| Process for Handling Referrals to FDA Under 21 CFR 50.54 Additional Safeguards for Children in Clinical Investigations [PDF] |
Final |
12/22/2006 |
| Qualifying for Pediatric Exclusivity Under Section 505A of the Federal Food, Drug, and Cosmetic Act |
Final |
9/1999 |
| Refusal to File |
Final |
7/12/1993 |
| Repeal of Section 507 of the Federal Food, Drug and Cosmetic Act |
Final |
Revised 5/1998, |
| Reports on the Status of Postmarketing Study Commitments — Implementation of Section 130 of the Food and Drug Administration Modernization Act of 1997 |
Final |
2/15/2006 |
| Special Protocol Assessment |
Final |
5/2002 |
| Standards for Prompt Review of Efficacy Supplements |
Final |
5/15/1998 |
| Standards for Securing the Drug Supply Chain - Standardized Numerical Identification for Prescription Drug Packages |
Draft |
1/22/2009 |
| Submission of Patent Information for Certain Old Antibiotics |
Draft |
11/28/2008 |
| Submitting and Reviewing Complete Responses to Clinical Holds (Revised) |
Final |
10/2000 |
| Submitting Debarment Certification Statements |
Draft |
10/2/98 |
| Submitting Marketing Applications According to the ICH/CTD Format: General Considerations |
Draft |
9/5/2001 |
| Target Product Profile -- A Strategic Development Process Tool |
Draft |
3/29/2007 |
| Technical Considerations for Pen, Jet, and Related Injectors Intended for Use With Drugs and Biological Products |
Draft |
6/2/2009 |
| The Use of Clinical Holds Following Clinical Investigator Misconduct |
Draft |
4/2002 |
| Tropical Disease Priority Review Vouchers |
Draft |
10/21/2008 |
| Useful Written Consumer Medication Information (CMI) |
Final |
7/17/2006 |
| Using a Centralized IRB Review Process in Multicenter Clinical Trials |
Final |
3/15/2006 |
| Waiver of IRB Requirements for Drug and Biological Product Studies |
Final |
1/2006 |
| Women and Minorities Guidance Requirements |
Final |
7/20/1998 |
