FDA Releases Guideline on Animal Drug Substance CMC Filings in CTD Format

FDA’s Center for Veterinary Medicine (CVM) has released a guideline on how to file drug substance CMC information for new and abbreviated new animal drug applications (NADAs/ANADAs) in the Common Technical Document (CTD) format.  The CMC guideline was released as a final version rather than as a draft for comment.

The NADA/ANADA drug substance CMC guideline fills in a gap that was left with the 2006 withdrawal of a 1987 umbrella guideline on the Format and Content of a Chemistry, Manufacturing, and Controls Section of an Application that encompassed both human and animal drug filings.  The umbrella guideline was withdrawn along with a handful of others that FDA deemed  “inconsistent with the agency’s initiative, Pharmaceutical Current Good Manufacturing Practices (CGMPs) for the 21st Century.”

[More on the background and content of the CVM guideline along with relevant links is provided for subscribers here.]