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The Chemistry, Manufacturing, and Controls (CMC) technical section is one portion of an original new animal drug application (NADA), abbreviated new animal drug application (ANADA), conditional new animal drug application (CNADA) and must contain full information regarding the manufacture of the new animal drug substance and new animal drug product.  Animal drug manufacturing processes must be robust and able to produce drug product batches of consistent identity, strength, quality, and purity.  Primary batches of drug product are manufactured as part of the original application.  Data from these batches are used to establish that the manufacturing, sampling, and control processes described in the CMC portion of the application will consistently provide a quality, stable drug product that, within a batch and on a batch-to-batch basis, does not vary beyond the established specification(s).  Additionally, they are used in studies to establish that the drug product is safe and effective (or in the case of an ANADA, bioequivalent to the reference listed new animal drug).  As such, the primary batches demonstrate that the applicant can consistently manufacture batches of same quality as those used in safety and effectiveness (or bioequivalence) studies.  This guidance provides recommendations for the primary batches of drug product manufactured to support the approval or conditional approval of new animal drug products.

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