Guidances (Drugs)

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

Newly Added and Withdrawn Guidances

Additional Information

  • 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 


Page Last Updated: 03/05/2019
Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English