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.
If you cannot find the document you’re looking for here, you can browse separate collections of guidance documents by topic.
Go to Guidance Document Search
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
10903 New Hampshire Avenue
WO Bldg. 1, room 4208
Silver Spring, MD 20993
Phone : 301-796-8530
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.
Guidance Document Search
Some table information
| Summary | Document | Issue date | FDA Organization | regulated product taxonomy hidden | Topic old hidden | Topic | Guidance Status | Open for Comment | Comment Closing Date on Draft | Docket Number | Guidance Type hidden | center taxonomy hidden | regulated product parent taxonomy hidden |
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