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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Not for implementation.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.

This guidance is being distributed for comment purposes only.

Submit Comments by

Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the FDA considers your comment on a draft guidance before it begins work on the final version of the guidance, submit either online or written comments on the draft guidance before the close date.

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


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.

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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