← FDA GUIDANCE
FDA GUIDANCE · DRAFTSeptember 17, 2024
CVM GFI #227 Chemistry, Manufacturing, and Controls (CMC) Technical Section Filing Strategies
What this record is not
Guidance details are published by the U.S. FDA; SPEQ surfaces them for reference and is not affiliated with or endorsed by the FDA. The authoritative text is on fda.gov.
Status
Draft
Topic
Premarket, Animal Drugs, Chemistry, Manufacturing, and Controls (CMC), Investigational New Animal Drug (INAD), New Animal Drug Application (NADA)
Issue date
September 17, 2024
This is a draft guidance — issued for comment and not for implementation. It signals FDA’s current thinking and the direction of a requirement, but the final document may change. Track the comment window on the FDA page.
READ THE FULL GUIDANCE
The complete guidance document — every recommendation and its scope — is published by the FDA. SPEQ surfaces and indexes it for reference; the authoritative text lives on fda.gov.
View on fda.gov →