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  1. Search for FDA Guidance Documents

Guidance documents describe FDA’s interpretation of or policy on a regulatory issue (21 CFR 10.115(b)). In general, FDA’s guidance documents do not establish legally enforceable responsibilities and thus are not binding on FDA or the public. Instead, guidances describe the Agency’s current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited. You can use an alternative approach if the approach satisfies the requirements of the applicable statutes and regulations. 

Search for FDA Guidance Documents

This feature is provided to give a convenient way to search for all FDA guidance documents from a single location.

Search for FDA Guidance Documents



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