CVM GFI #216 Chemistry, Manufacturing, and Controls (CMC) Information - Fermentation-Derived Intermediates, Drug Substances, and Related Drug Products for Veterinary Medicinal Use
- Docket Number:
- Issued by:
Guidance Issuing OfficeCenter for Veterinary Medicine
This guidance provides recommendations on what documentation to submit to support the chemistry, manufacturing, and controls (CMC) information for fermentation-derived intermediates, drug substances, and related drug products for veterinary medicinal use. This information is filed to the Center for Veterinary Medicine (CVM) in a new animal drug application (NADA), conditional new animal drug application (CNADA), investigational new animal drug file (INAD), abbreviated new animal drug application (ANADA), generic investigational new animal drug file (JINAD), drug master file (DMF), or veterinary master file (VMF).
You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))
If unable to submit comments online, please mail written comments to:
Division of Dockets Management (HFA- 305)
Food and Drug Administration
5630 Fishers Lane, Rm. 1061
Rockville, MD 20852
All written comments should be identified with this document's docket number: FDA-2011-D-0112.