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GUIDANCE DOCUMENT

CVM GFI #216 Chemistry, Manufacturing, and Controls (CMC) Information - Fermentation-Derived Intermediates, Drug Substances, and Related Drug Products for Veterinary Medicinal Use March 2012

Final
Docket Number:
FDA-2011-D-0112
Issued by:
Guidance Issuing Office
Center 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).
 


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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:

Dockets Management
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.

Questions?

Contact Point
CVM
Center for Veterinary Medicine
Food and Drug Administration
7500 Standish Pl, HFV-1
Rockville, MD 20855
AskCVM@fda.hhs.gov
(240) 402-7002