Dispute Resolution Procedures for Science Based Decisions on Products Regulated by the CVM

This information collection supports agency guidance and applicable regulations. The guidance describes policy for resolution of disputes relating to scientific controversies within the Center for Veterinary Medicine at FDA. 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 specialize education, training or experience 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 relating to regulated products for animals.

The latest form for Dispute Resolution Procedures for Science Based Decisions on Products Regulated by the CVM expires 2021-03-31 and can be found here.