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U.S. Department of Health and Human Services

For Industry

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Industry Notices and Guidance Documents

 

 

Industry Notices 

Notices to industry on technical and regulatory topics

 

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.

Browse Guidance Documents by Topic

More on guidance documents: FDA Basics for Industry

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