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Guidances

Guidances

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The table below lists all official FDA Guidance Documents and other regulatory guidance. You can search for documents using key words, and you can narrow or filter your results by product, date issued, FDA organizational unit, type of document, subject, draft or final status, and comment period.

This feature is provided to give a convenient way to search for all FDA guidance documents from a single location. We will continue to refine it as we observe its performance.

If you cannot find the document you’re looking for here, you can browse separate collections of guidance documents by topic.

(Search results update automatically as you type)

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Title Date issued FDA Organization Subject Draft or Final Open for Comment Comment Closing Date on Draft* Docket Number

* The public can comment on FDA guidance documents at any time. Typically, for draft guidance documents, the agency designates a comment period so that these comments on the document can be considered as the draft is finalized.

About FDA Guidance Documents

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

Some Web links (URLs) embedded within guidance documents may have changed since the document was published. 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.

Commenting on Guidance Documents

Some FDA guidance documents on this list are indicated as open for comment. Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the Agency considers your comment on a draft guidance that is open for comments before it begins work on the final version of the guidance, submit either electronic or written comments by the closing date. Comments are submitted electronically through regulations.gov. For more information, see:

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."

 

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