About 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.
Good Guidance Practices and Agenda
FDA's Good Guidance Practices regulation (PDF - 162KB) September 2000
Newly Added and Withdrawn Guidances
Withdrawn Guidance Documents (coming soon)
- 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