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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:

Submit Comments on the Annual Guidance Agenda (Federal Register July 9, 2004)

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