Meetings & Presentations

There are currently no meetings scheduled.

Presentations

• Minor Use Minor Species Grants
• 2022 Aquaculture Drug Approval Coordination Workshop – Update on Indexing

On December 22, 2023, FDA finalized Guidance for Industry #61, entitled “Special Considerations, Incentives, and Programs to Support the Approval of New Animal Drugs for Minor Uses and for Minor Species,” to help researchers and animal drug sponsors navigate the pathway to approval for animal drugs intended for minor uses and minor species. As part of the release of the draft revised GFI #61 on July 14, 2020, FDA provided the following presentations. Although comments to the draft revised guidance are now closed, the information in these presentations is still applicable to the final guidance.

• Part 1: Introduction and Overview
• Part 2: Minor Use Determinations and MUMS Designation Incentives
• Part 3: New Animal Drug Approval Process
• Part 4: Special Considerations for Aquatic Species