FDA Guidance
Documents
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Guidance documents represent FDA's current thinking on a topic. They do not create or confer any rights for or on any person and do not operate to bind FDA or the public. You can use an alternative approach if the approach satisfies the requirements of the applicable statutes and regulations.
If you believe an FDA employee is not following FDA's Good Guidance Practice regulations (21 CFR 10.115) or the Office of Management and Budget's Bulletin No. 07-02(M-07-07) Final Bulletin for Agency Good Guidance Practices (January 18, 2007), you should contact the employee's supervisor in the issuing office or Center. If the issue is not resolved, contact the next highest supervisor or the Center's Ombudsman. If the issue is still not resolved, contact the FDA's Office of the Ombudsman at:
FDA Office of the Ombudsman
5600 Fishers Lane, Rm. 13B-07
Rockville, MD 20857
Phone: 301-827-3390
Fax: 301-480-8039
Email: Ombuds@oc.fda.gov
Guidance Documents from FDA's Centers:
Office of the Commissioner:
- Guidance
for Sponsors, Industry, Researchers, Investigators, and Food and Drug
Administration Staff: 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 (January 2009) New!
- Draft Guidance for Industry:
Standards for Securing the Drug Supply Chain - Standardized Numerical Identification
for Prescription Drug Packages (January 2009) New!
- Guidance for Industry: Submission
Of Laboratory Packages By Accredited Laboratories (January 2009) New!
- Guidance
for Industry: Voluntary Third-Party Certification Programs for Foods
and Feeds (January 2009) New!
- 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 U.S. (January
2009) New!
- Draft Guidance: Good Importer Practices (January 2009) New!
- Guidance for Industry on CGMP for Phase 1 Investigational Drugs (July 2008)
- Draft Guidance for Industry on Providing Regulatory Submissions in Electronic Format – Drug Establishment Registration and Drug Listing | PDF [112KB] (July 2008)
- Emergency Use Authorization of Medical Products (July 2007)
- Exports Under the FDA Export
Reform and Enhancement Act of 1996 (PDF, 233 KB)
- Computerized Systems Used in Clinical Trials [PDF] (May 10, 2007)
- Draft 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 Draft Guidance for comment (March 2007)
- Guidance for Industry
Complementary and Alternative Medicine Products and Their Regulation by the Food and Drug Administration Draft Guidance for comment (February 2007)
- Guidance for Industry: Advisory Committee Meetings — Preparation and Public Availability of Information Given to Advisory Committee Members Draft Guidance for comment (February 2007)
- Annual Comprehensive
List of Guidance Documents (Federal Register Sept. 2, 2006)
- Early Development Considerations for Innovative Combination Products (September 2006)
- Final Guidance: Using Electronic Means to Distribute Certain Product Information (March 2006)
- Application User Fees for Combination Products (April 2005)
- Correction
to Comprehensive List (PDF)
(Federal Register Feb. 11, 2005)
- Conflict of Interest Disclosure
Guidance (January 2002)
- Small Business
Guide to FDA
- FDA Guidance -- Financial Disclosure
by Clinical Investigators (March 20, 2001)
- Guidance for FDA and
Industry: Direct Final Rule Procedures (Federal Register Nov.
21, 1997)
- Final Guidance on Industry-Supported
Scientific and Educational Activities (Federal Register Dec.
3, 1997)
Submit Comments on the Annual
Guidance Agenda (Federal
Register July 9, 2004)
