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GUIDANCE DOCUMENT

CVM GFI #218 Cell-Based Products for Animal Use June 2015

Download the Final Guidance Document Read the Federal Register Notice
Final
Docket Number:
FDA-2014-D-0634
Issued by:
Guidance Issuing Office
Center for Veterinary Medicine

The Food and Drug Administration’s (FDA) Center for Veterinary Medicine (CVM) is aware that many potential veterinary therapies may be produced using cell-based products. Developers of such products for veterinary use have approached CVM for clarification regarding the regulation of these products. This guidance for industry (GFI) describes CVM’s current thinking on cell-based products for animal use that meet the definition of a “new animal drug.”

This guidance is for persons developing, manufacturing, or marketing cell-based products for animal use, including “animal stem cell-based products” (ASCPs). CVM encourages all such persons to contact the Center early in product development.

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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-2014-D-0634.

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