Drugs

Guidances (Drugs)

All FDA Guidances

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 contact the originating office.  Another method of obtaining guidance documents is through the Division of Drug Information.

FDA's move to the White Oak Campus means that names, addresses, and phone numbers listed in Agency guidances may no longer be accurate.  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).

Notice Web link Changes: We have recently redesigned the FDA Web site. As a result, some Web links (URLs) embedded within guidance documents are no longer valid. If you find a link that does not work, please try searching for the document using the document title. For more assistance, go to Contact FDA.

Information About Guidances

 The category “Chemistry, Manufacturing, and Controls (CMC) is renamed to Pharmaceutical Quality/CMC.

 The category “CMC – Microbiology (Chemistry, Manufacturing and Controls) is renamed to Pharmaceutical Quality/Microbiology 

*Note: Draft guidances are undergoing finalization. Please contact the relevant division for the most up-to-date Agency perspective on an issue. For information on how to electronically submit a comment on a draft guidance, please see How to Comment on Proposed Regulations and Submit Petitions

Newly Added Guidance Documents Guidance Documents will be retained in this section of 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.

Page Last Updated: 12/16/2014
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