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

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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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