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:
10903 New Hampshire Avenue
WO 32, Room 4231
Silver Spring, MD 20993
Report on Good Guidance Practices
As part of the FDA's Transparency Initiative, Dr. Margaret A. Hamburg, the Commissioner of Food and Drugs, called for a cross-Agency working group to prepare a report identifying FDA's "best practices" for making the agency’s guidance development processes more transparent and efficient.
The working group prepared a report, entitled "Food and Drug Administration Report on Good Guidance Practices: Improving Efficiency and Transparency."
- Fact Sheet: FDA Good Guidance Practices
- Report on Good Guidance Practices: Improving Efficiency and Transparency
- Federal Register Notice of Availability
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