Regulatory Information

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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.

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

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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 Typically, for draft guidance documents, the agency designates a comment period so that these comments on the document can be considered as the draft is finalized.

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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