What Is FDA Guidance?

Guidance documents represent the Agency’s current thinking on a particular subject.  They do not create or confer any rights for or on any person and do not operate to bind FDA or the public.

An alternative approach may be used if such approach satisfies the requirements of the applicable statute, regulations, or both.

For information on a specific guidance document, please refer to the FDA’s originating office.  Another method of obtaining guidance documents is through the Division of Drug Information.

If you need to speak to someone, contact the office or division that developed a guidance (see footnote 1 in guidances) or contact CDER’s Division of Drug Information (use link above).

FDA’s Good Guidance Practices Regulation – Download Below.


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Download “FDA Drug: Comprehensive List Of Guidances” Comprehensive-List-Of-GuidancesNew_12-31-13.pdf – Downloaded 2 times – 209 KB

FDA CDER: Newly Added Guidance Documents

  • Guidance Documents are retained in the page for a period of three months.  The most recently added appears first and they are in the order of the date they were issued.

Last Updated: 2015-08-08