CVM GFI #79 Dispute Resolution Procedures for Science-Based Decisions on Products Regulated by CVM May 2014
- Docket Number:
- Issued by:
Guidance Issuing OfficeCenter 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.
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:
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.