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.
Filter by FDA Organization, Center for Drug Evaluation and Research, for all the guidances related to drugs.
Good Guidance Practices and Agenda
- FDA's Good Guidance Practices regulation (PDF - 162KB) September 2000
- How to comment on Guidance Documents
- Instructions for Submitting Drafts of Proposed Guidance Documents Electronically
- Guidance Agenda: Guidances CDER is Planning to Develop During Calendar Year 2020 (PDF - 65KB) (updated 01/30/2020)
Newly Added and Withdrawn Guidances
- Guidance Agenda 2020
- Newly Added Guidance Documents
- Product-Specific Guidances for Generic Drug Development
- Spanish Language Guidances