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Guidance Development - Background

Transparency Report Arrow Background

Summary of Public Comments


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FDA has issued regulations that govern the development, issuance, and use of guidance documents.   These regulations provide that as part of the agency’s guidance development process, FDA will post on the FDA Web site a list of guidances the agency may work on during the next year.   This list, however, does not indicate the Center’s priority topics for completion nor are timeframes through publication of the final guidance document provided.

Members of the public can also submit written comments to FDA about draft guidance documents (public comment is not solicited for guidance documents that set forth existing practice or minor changes in interpretation or policy).   Interested members of the public can also suggest areas for guidance development,  submit drafts of guidance documents for FDA to consider,  and suggest that FDA revise or withdraw an existing guidance document.

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