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GUIDANCE DOCUMENT

CVM GFI #290 (VICH GL61) – Pharmaceutical Development May 2024

Download the Draft Guidance Document Read the Federal Register Notice
Draft

Not for implementation. Contains non-binding recommendations.

This guidance is being distributed for comment purposes only.

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Submit Comments Online

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can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the FDA considers your comment on a draft guidance before it begins work on the final version of the guidance, submit either online or written comments on the draft guidance before the close date.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-1133

Docket Number:
FDA-2024-D-1133
Issued by:
Guidance Issuing Office
Center for Veterinary Medicine

This guidance describes the suggested contents for the Pharmaceutical Development section for veterinary medicinal products, which provides an opportunity to present the knowledge gained through the application of scientific approaches and quality risk management to the development of a product and its manufacturing process.  It is first produced for the original marketing application and can be updated to support new knowledge gained over the lifecycle of a product.  

Questions?

Contact Point
Mai Huynh
Center for Veterinary Medicine
Office of New Animal Drug Evaluation
Food and Drug Administration
7500 Standish Place, HFV-140
Rockville, MD 20855
Mai.Huynh@fda.hhs.gov
240-402-0669
 
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