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GUIDANCE DOCUMENT

CVM GFI #288 Chemistry, Manufacturing, and Controls in Support of Recombinant Protein Products for Veterinary Medicinal Use June 2024

Draft

Not for implementation. Contains non-binding recommendations.

Docket Number:
FDA-2024-D-1668
Issued by:
Guidance Issuing Office
Center for Veterinary Medicine

Recombinant proteins are produced with recombinant deoxyribonucleic acid (DNA) technology. The production of recombinant proteins has unique characteristics; therefore, the information related to manufacture, characterization, and stability may differ from published guidances specific to synthetic chemical substances.  This guidance describes the Center for Veterinary Medicine’s recommendations for the information to be included in Chemistry, Manufacturing, and Controls submissions to New Animal Drug Applications, Conditional New Animal Drug Applications, Investigational New Animal Drug files, and Veterinary Master Files specific to recombinant protein-based intermediates,  drug substances, and drug products.


Submit Comments

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-1668.

Questions?

Contact Point
Lijuan He
Center for Veterinary Medicine
Food and Drug Administration
7500 Standish Place, HFV-144
Rockville, MD 20855
Lijuan.He@fda.hhs.gov
301-796-5122
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