FDA releases draft Guidance for Industry #61 related to approval of new animal drugs for minor use and minor species, comment period opens tomorrow

July 15, 2020

This morning, the FDA’s Center for Veterinary Medicine released revised draft Guidance for Industry #61, entitled “Special Considerations, Incentives, and Programs to Support the Approval of New Animal Drugs for Minor Uses and for Minor Species,” in order to better facilitate the availability of safe and effective new animal drugs for minor uses and minor species (MUMS).

Revised draft GFI #61 replaces a previous version, entitled “FDA Approval of New Animal Drugs for MUMS.” The revised draft guidance is a thorough revision and reorganization in chronological “guidebook” fashion intended to be helpful to all sponsors, but especially for those new to the process. The revision also highlights special considerations for drugs for aquaculture.

The public comment period for dGFI #61 will be open for 120 days, starting Wednesday, July 15, 2020. Comments will be accepted at any time but should be submitted no later than Thursday, November 12, 2020, to ensure that the FDA takes the information into consideration before making further decisions on this issue.

To electronically submit comments to the docket, visit www.regulations.gov and type FDA-1997-D-0444 in the search box. For assistance in submitting electronic comments, please see regulations.gov help.

To submit comments to the docket by mail, use the following address. Be sure to include docket number FDA-1997-D-0444 on each page of your written comments.

For additional information, please see the links below. I am also available to answer any questions you may have.

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