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GUIDANCE DOCUMENT

CVM GFI #79 Dispute Resolution Procedures for Science-Based Decisions on Products Regulated by CVM May 2014

Final
Docket Number:
FDA-2003-D-0307
Issued by:
Guidance Issuing Office
Center for Veterinary Medicine

This guidance document describes a recommended approach for resolution of disputes relating to scientific controversies.  A scientific controversy involves issues that arise within the context of the Center’s regulation of a specific product and are related to matters of technical expertise that require some specialized education, training, or experience in order to be understood and resolved.  The guidance document describes the dispute resolution procedures that we recommend be followed by sponsors, applicants, and manufacturers when requesting review of FDA decisions related to regulated products for animals.


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-2003-D-0307.

Questions?

Contact Point
CVM
Center for Veterinary Medicine
Food and Drug Administration
7500 Standish Pl, HFV-1
Rockville, MD 20855
AskCVM@fda.hhs.gov
(240) 402-7002