Procedural

Title and Format	Type	Issue Date
180-Day Generic Drug Exclusivity Under the Hatch-Waxman Amendments to the Federal Food, Drug, and Cosmetic Act (PDF - 77KB)	Final	6/1998
Applications Covered by Section 505(b)(2)(PDF - 41KB)	Draft	10/1999
Citizen Petitions and Petitions for Stay of Action Subject to Section 505(q) of the Federal Food, Drug, and Cosmetic Act (PDF - 115KB)	Final	6/8/2011
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 (PDF - 64KB)	Final	2/22/2008
Continuous Marketing Applications: Pilot 1 – Reviewable Units for Fast Track Products Under PDUFA  (PDF - 195 KB)	Final	Withdrawn 4/9/2010
Continuous Marketing Applications: Pilot 2 – Scientific Feedback and Interactions During Development of Fast Track Products Under PDUFA  (PDF - 168 KB) Paperwork Reduction Act Burden Statement  (PDF - 72 KB) (Posted 7/27/2004)	Final	Withdrawn 4/9/2010
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  (PDF - 25KB)	Final	Posted 3/27/2000
Dear Health Care Provider Letters:Improving Communication of Important Safety Information (PDF - 178KB)	Draft	11/15/2010
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 (PDF - 30KB)	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 (PDF - 10KB)	Final	11/1999
Drug Products Containing Ensulizole, Hypromellose, Meradimate, Octinoxate, and Octisalate — Labeling Enforcement Policy (PDF - 159KB)	Final	6/3/2003
Electronic Source Documentation in Clinical Investigations (167 KB)	Draft	1/6/2011
Emergency Use Authorization of Medical Products	Final	2007
End-of-Phase 2A Meetings (PDF - 163KB)	Final	9/18/2009
Enforcement Policy During Implementation of Section 503A of the Federal Food, Drug, and Cosmetic Act	Withdrawn	9/2008
Enforcement Policy -- OTC  Sunscreen Drug Products Marketed Without an Approved Application (PDF-84KB)	Draft	6/14/2011
Fast Track Drug Development Programs - Designation, Development, and Application Review (PDF - 83KB) Appendix 2 (PDF - 3930 KB)  [Appendices are scanned copies, which will be replaced by final versions] (Issued 11/17/1998, Posted 11/17/1998)	Final	1/12/2006
FDA Export Certificates	Final	7/2004
FDA Oversight of PET Drug Products Questions and Answers (PDF - 1,040KB)	Draft	2/24/2012
Financial Disclosure by Clinical Investigators	Draft	5/24/2011
Fixed Dose Combinations, Co-Packaged Drug Products, and Single-Entity Versions of Previously Approved Antiretrovirals for the Treatment of HIV (PDF - 343KB)	Final	10/17/2006
Formal Dispute Resolution: Appeals Above the Division Level (PDF - 30KB)	Final	2/2000
Formal Meetings Between the FDA and Sponsors or Applicants (PDF - 89KB)	Final	5/19/2009
Forms for Registration of Producers of Drugs and Listing of Drugs in Commercial Distribution (PDF - 32KB)	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 (PDF - 683KB)	Final	3/2005
Guidance for FDA Staff: The Leveraging Handbook; An Agency Resource for Effective Collaborations (PDF - 143KB)	Final	Revised 6/2003
Guidance for Clinical Investigators, Sponsors, and IRBs Adverse Event Reporting to IRBs — Improving Human Subject Protection (PDF - 61KB)	Final	1/14/2009
Guidance for IRB's Clinical Investigators, and IRBs - Continuing Review after Clinical Investigation Approval (PDF - 145KB)	Final	2/2012
Guidance for Sponsors, Clinical Investigators, and IRBs; Data Retention When Subjects Withdraw From FDA-Regulated Clinical Trials (PDF - 399KB)	Draft	12/2/2008
How to Comply with the Pediatric Research Equity Act (PDF - 116KB)	Draft	9/7/2005
Implementation of Section 120 of the Food and Drug Administration Modernization Act of 1997-Advisory Committees (PDF - 62KB)	Final	10/1998
Implementation of Section 126 of the Food and Drug Administration Modernization Act of 1997 - Elimination of Certain Labeling Requirements (PDF - 979KB)	Final	7/1998
In Vitro Companion Diagnostic Devices; Draft Guidance for Industry and Food and Drug Administration Staff	Draft	7/14/2011
Independent Consultants for Biotechnology Clinical Trial Protocols	Final	8/18/2004
Information Program on Clinical Trials for Serious or Life-Threatening Diseases and Conditions (PDF - 40KB) [Revision 1]	Draft	1/2004
Information Program on Clinical Trials for Serious or Life-Threatening Diseases and Conditions (PDF - 34KB)	Final	3/2002
Information Request and Discipline Review Letters Under the Prescription Drug User Fee Act (PDF - 27KB)	Final	11/2001
Information Sheet Guidance for Sponsors, Clinical Investigators, and IRBs Frequently Asked Questions - Statement of Investigator (Form FDA 1572) (PDF - 105KB)	Final	6/4/2010
Integrated Summaries of Effectiveness and Safety: Location Within the Common Technical Document (PDF - 98KB)	Final	4/20/2009
Integrated Summary of Effectiveness (PDF - 95KB)	Draft	7/26/2008
Investigator Responsibilities — Protecting the Rights, Safety, and Welfare of Study Subjects (PDF - 163KB)	Final	10/23/2009
Levothyroxine Sodium Products Enforcement of August 14, 2001 Compliance Date and Submission of New Applications (PDF - 24KB)	Final	7/2001
Medication Guides — Adding a Toll-Free Number for Reporting Adverse Events (PDF - 67KB)	Final	6/8/2009
National Uniformity for Nonpresciption Drugs - Ingredient Listing for OTC Drugs (PDF - 74KB)	Final	4/1998
Notification to FDA of Issues that May Result in a Prescription Drug or Biological Product Shortage (PDF - 225KB)	Draft	2/21/2012
Oversight of Clinical Investigations — A Risk-Based Approach to Monitoring (PDF -150KB)	Draft	8/29/11
PET Drug Applications - Content and Format for NDAs and ANDAs (PDF - 430KB) Attachment I: Sample formats for chemistry, manufacturing, and controls sections (PDF - 615KB)  Attachment II: Form FDA 356h (PDF - 602KB) Sample Labels in SPL format	Final	8/31/2011
Pharmacogenomic Data Submissions (PDF - 96KB) Examples of Voluntary Submissions or Submissions Required Under 21 CFR 312, 314, or 601  (PDF - 63KB)	Final	3/2005
Pharmacogenomic Data Submissions — Companion Guidance (PDF - 211KB)	Draft	8/28/2007
Planning for the Effects of High Absenteeism to Ensure Availability of Medically Necessary Drug Products (PDF - 82KB)	Final	3/14/2011
Postmarketing Safety Reporting for Human Drug and Biological Products Including Vaccines (PDF - 375KB)	Draft	3/9/2001
Potassium Iodide as a Thyroid Blocking Agent in Radiation Emergencies  (PDF - 40KB) KI in Radiation Emergencies-Questions and Answers (PDF - 161KB)	Final	12/10/2001 12/23/2002
Potassium Iodide Tablets - Shelf Life Extension (PDF - 156KB)	Final	3/8/2004
Procedures for Determining Conflict of Interest and Eligibility for Participation in FDA Advisory Committees (PDF - 68KB)	Final	8/2008
Process for Handling Referrals to FDA Under 21 CFR 50.54 Additional Safeguards for Children in Clinical Investigations (PDF - 116KB)	Final	12/22/2006
Qualifying for Pediatric Exclusivity Under Section 505A of the Federal Food, Drug, and Cosmetic Act (PDF - 57KB)	Final	9/1999
Refusal to File (PDF - 304KB)	Final	7/12/1993
Repeal of Section 507 of the Federal Food, Drug and Cosmetic Act (PDF - 85KB)	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 (PDF - 456KB)	Final	2/15/2006
Responding to Unsolicited Requests for Off-Label Information About Prescription Drugs and Medical Devices (PDF - 258 KB)	Draft	12/27/2011
Special Protocol Assessment (PDF - 36KB)	Final	5/2002
Standards for Prompt Review of Efficacy Supplements (PDF - 76KB)	Final	5/15/1998
Standards for Securing the Drug Supply Chain - Standardized Numerical Identification for Prescription Drug Packages	Final	3/26/2010
Submission of Patent Information for Certain Old Antibiotics (PDF - 42KB)	Draft	11/28/2008
Submitting and Reviewing Complete Responses to Clinical Holds (Revised)(PDF - 26KB)	Final	10/2000
Submitting Debarment Certification Statements (PDF - 144KB)	Draft	10/2/98
Submitting Marketing Applications According to the ICH/CTD Format: General Considerations (PDF - 50KB)	Draft	9/5/2001
Target Product Profile -- A Strategic Development Process Tool (PDF - 454KB)	Draft	3/29/2007
Technical Considerations for Pen, Jet, and Related Injectors Intended for Use With Drugs and Biological Products (PDF - 112KB)	Draft	6/2/2009
The Use of Clinical Holds Following Clinical Investigator Misconduct (PDF - 33KB)	Draft	4/2002
Toll-Free Number Labeling and Related Requirements for Over-the-Counter and Prescription Drugs Marketed With Approved Applications (PDF - 119KB)	Final	6/14/2012
Tropical Disease Priority Review Vouchers (PDF - 112KB)	Draft	10/21/2008
Use of Histology in Biomarker Qualification Studies (PDF - 298KB)	Draft	12/29/2011
Useful Written Consumer Medication Information (CMI)(PDF - 73KB)	Final	7/17/2006
Using a Centralized IRB Review Process in Multicenter Clinical Trials (PDF - 87KB)	Final	3/15/2006
Waiver of IRB Requirements for Drug and Biological Product Studies (PDF - 35KB)	Final	1/2006
Women and Minorities Guidance Requirements (PDF - 30KB)	Final	7/20/1998