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GUIDANCE DOCUMENT

CVM GFI #285 - Manufacture of Batches in Support of Original NADAs, ANADAs, and CNADAs March 2024

Download the Draft Guidance Document Read the Federal Register Notice
Draft

Not for implementation. Contains non-binding recommendations.

Docket Number:
FDA-2024-D-1054
Issued by:
Guidance Issuing Office
Center for Veterinary Medicine

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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Submit Comments Online

You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))

If unable to submit comments online, please mail written comments to:

Dockets Management
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852

All written comments should be identified with this document's docket number: FDA-2024-D-1054.

Questions?

Contact Point
Amy Simms
Center for Veterinary Medicine
Food and Drug Administration
7500 Standish Place, HFV-140
Rockville, MD 20855
Amy.Simms@fda.hhs.gov
240-402-0648
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