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  1. Guidance & Regulations

Chemistry Manufacturing and Controls (CMC) Guidances for Industry (GFIs)

Chemistry Manufacturing and Controls (CMC) Guidances for Industry (GFIs)

CVM CMC Guidances

Other CMC Guidances

CMC Guidance Documents Applicable to Minor Use or Minor Species (MUMS) Animal Drugs, Biotech Animal Drugs, and Biotherapeutics

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


CVM CMC Guidances

Administrative and General Guidances

Manufacturing Guidances

Analytical Controls Guidances

Impurities Guidances

Stability Guidances

Post-approval Changes Guidances

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Other CMC Guidances

Other FDA guidances may also provide useful information for the submission of CMC information for animal drugs, including Cross-Center guidances, Center for Drug Evaluation and Research (CDER) guidances, and International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) guidances. Any other Cross-Center, CDER, or ICH guidance pertaining to CMC information may also be considered applicable to animal drugs. Drug sponsors should contact CVM’s Division of Manufacturing Technologies if they have any questions regarding the applicability of a guidance to animal drugs. For further information, contact AskCVM@fda.hhs.gov.

Administrative and General Guidances

Manufacturing Guidances

Analytical Control Guidances

Container Closure Guidances

Impurities Guidances

Post-approval Changes Guidances

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CMC Guidance Documents Applicable to Minor Use or Minor Species (MUMS) Animal Drugs, Biotech Animal Drugs, and Biotherapeutics

Guidances are available that may also provide useful information for the submission of CMC information for Minor Use or Minor Species (MUMS) animal drugs, biotech animal drugs, and biotherapeutics. These other guidances include Cross-Cutting guidances, CBER guidances, and ICH guidances. Any other guidances pertaining to CMC information in addition to those listed below may also be applicable to such animal drugs. Drug sponsors considering an approach outlined in these CMC guidances should contact CVM’s Division of Manufacturing Technologies if they have any questions regarding the applicability of a guidance to MUMS, biotech, or biotherapeutic animal drugs. For further information, contact AskCVM@fda.hhs.gov.

Administrative/General/Manufacturing Guidances

Analytical Controls Guidances

Stability Guidances

Post-approval Changes Guidances

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

CVM has guidances (including VICH guidances) that cover many CMC topics that are applicable not only to new animal drug applications, but also to original and supplemental abbreviated new animal drug applications (ANADAs) and generic investigational new animal drug files (JINADs). Other FDA guidances (i.e., CDER CMC guidances) may also provide useful information for the submission of CMC information for generic animal drugs. Any other guidance pertaining to CMC information in addition to those listed below may also be 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 to generic animal drugs. For further information, contact AskCVM@fda.hhs.gov

Manufacturing Guidances

Analytical Controls Guidances

Impurities Guidances

Stability Guidances

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