FDA Releases New Veterinary CMC Guidance
Posted 07 March 2012 | By
The US Food and Drug Administration (FDA) is releasing new guidance for industry for chemistry, manufacturing and controls (CMC) information relating to fermentation-derived products, including intermediates, drug substances and related drug products for veterinary medicinal use.
The guidance "provides recommendations on what documentation to submit to support the [CMC] information" for veterinary products to the Center for Veterinary Medicine (CVM).
"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)," writes CVM in the Federal Register posting.
FDA notes that the fermentation process has evolved to include a broad variety of products, including biomass products, competitive exclusion products, bacteriophage products and biotechnology products. These all have the potential to introduce "manufacturing variability" that can affect the purity, quality, safety and effectiveness of a product if not adequately controlled.
Federal Register - Guidance for Industry on Chemistry, Manufacturing, and Controls Information; Availability: Fermentation-Derived Intermediates, Drug Substances, and Related Drug Products for Veterinary Medicinal UseGuidance for Industry - Chemistry, Manufacturing, and Controls (CMC) Information - Fermentation-Derived Intermediates, Drug Substances, and Related Drug Products for Veterinary Medicinal Use