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:
- Draft Guidance for Industry on Good Reprint Practices for the Distribution of Medical Journal Articles and Medical or Scientific Reference Publications on Unapproved New Uses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 (February 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- Draft Guidance for the Public, FDA Advisory Committee Members, and FDA Staff on Procedures for Determining Conflict of Interest and Eligibility for Participation in FDA Advisory Committees Draft Guidance for comment (March 2007)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Complementary and Alternative Medicine Products and Their Regulation by the Food and Drug Administration Draft Guidance for comment (February 2007)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Advisory Committee Meetings — Preparation and Public Availability of Information Given to Advisory Committee Members Draft Guidance for comment (February 2007)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)
- FDA Guidance for Industry on:
Exports and Imports Under the FDA Export Reform and Enhancement Act of
1996 (Federal
Register June 12, 1998)
- 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)