Drugs

Pharmaceutical Quality/CMC

Below is a sortable table of Pharmaceutical Quality/CMC Guidances:

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

 

The guidance document entitled "Submitting Documentation for the Manufacturing of and Controls for Drug Products” was withdrawn 4/14/2015.  This guidance was withdrawn because many of the recommendations were obsolete and have been more recently addressed in FDA and ICH guidance documents, including, but not limited to:
 

Additional information is available on CDER’s web site (www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm).

If you have questions about submission of information on manufacturing and controls for drug products, please contact the Office of Communications, Division of Drug Information toll-free at 855-543-3784 (toll 301-796-3400) or by email at druginfo@fda.hhs.gov.

Page Last Updated: 04/28/2015
Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.