-
Regulatory Information
-
FDA Guidance Documents: General and Cross-Cutting Topics
We have recently redesigned the FDA Web site. As a result, some Web links (URLs) embedded within guidance documents are no longer valid. If you find a link that does not work, please try searching for the document using the document title. For more assistance, go to Contact FDA.
-
Guidance Documents:
- 03/01/2006 Using Electronic Means to Distribute Certain Product Information
- 01/01/2009 Voluntary Third-Party Certification Programs for Foods and Feeds
- 01/01/2009 Certifications To Accompany Drug, Biological Product, and Device Applications/Submissions: Compliance with Section 402(j) of The Public Health Service Act, Added By Title VIII of The Food and Drug Administration Amendments Act of 2007
- 01/01/2009 Submission Of Laboratory Packages By Accredited Laboratories
- 01/01/2009 Standards for Securing the Drug Supply Chain - Standardized Numerical Identification for Prescription Drug Packages
- 09/05/2003 (249) Part 11, Electronic Records; Electronic Signatures — Scope and Application (PDF - 215KB)
- 11/12/2002 Electronic Records; Electronic Signatures, Electronic Copies of Electronic Records (PDF - 143KB)
- 02/01/2008 Container and Closure System Integrity Testing in Lieu of Sterility Testing as a Component of the Stability Protocol for Sterile Products
- 08/01/2003 Part 11, Electronic Records; Electronic Signatures — Scope and Application
- 10/22/2003 Guidance for Industry - Providing Regulatory Submissions in Electronic Format — General Considerations
- 03/13/2001 Acceptance of Foreign Clinical Studies
- 09/24/2001 (246) 21 CFR Part 11; Electronic Records; Electronic Signatures,Validation; Draft Guidance for Industry (PDF - 202KB)
- 09/24/2001 (247) 21 CFR Part 11; Electronic Records; Electronic Signatures, Glossary of Terms; Draft Guidance for Industry (PDF - 117KB)
- 08/01/1999 Consumer-Directed Broadcast Advertisements
- 11/01/1997 Industry Supported Scientific and Educational Activities (PDF - 428KB)
- 01/01/2009 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
- 07/01/2007 Emergency Use Authorization of Medical Products
- 11/21/1997 Direct Final Rule Procedures
- 09/01/1997 The Sourcing and Processing of Gelatin to Reduce the Potential Risk Posed by Bovine Spongiform Encephalopathy (BSE) in FDA-Regulated Products for Human Use
- 05/01/2004 Fixed Dose Combination and Co-Packaged Drug Products for Treatment of HIV
- 03/01/2003 FDA Issues Food and Cosmetic Security Preventive Measures Guidance
- 12/01/2006 Complementary and Alternative Medicine Products and their Regulation by the Food and Drug Administration
-
-
-