Animal & Veterinary

Chemistry Manufacturing and Controls (CMC) Guidances

CMC Guidance Documents Applicable to Generic Animal Drug Products and Drug Substances

Chemistry Manufacturing and Controls (CMC)

CMC Guidance Documents Applicable to Generic Animal Drug Products and Drug Substances

Center for Veterinary Medicine (CVM) guidance documents are available that cover many Chemistry, Manufacturing, and Controls (CMC) topics that are applicable to original and supplemental abbreviated new animal drug applications (ANADAs) and generic investigational new animal drug files (JINADs). Other FDA guidance documents may also provide useful information for the submission of CMC information for generic animal drugs, including International Cooperation on Harmonization of Technical Requirements for Registration of Veterinary Medicinal Products (VICH) and Center for Drug Evaluation and Research (CDER) CMC guidance documents. VICH guidances provide information on a variety of topics applicable new animal drugs. Some of these guidances addressing CMC topics may also be applicable to generic animal drugs. CMC guidances developed by CDER for human drugs may also be applicable to generic animal drugs.

Any other VICH or CDER guidance document, in addition to those listed above, pertaining to CMC information may also be considered applicable to generic animal drugs. Drug sponsors should contact CVM’s Division of Manufacturing Technologies if they have any questions regarding the applicability of a guidance document to generic animal drugs.

For further information regarding this document, contact Heather Longstaff, Center for Veterinary Medicine (HFV-145), Food and Drug Administration, 7500 Standish Place, Rockville, MD 20855, 240-402-0651, e-mail: heather.longstaff@fda.hhs.gov.

Page Last Updated: 04/11/2016
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