U.S. flag An official website of the United States government
  1. Home
  2. Regulatory Information
  3. Search for FDA Guidance Documents
  4. CVM GFI #61 Special Considerations, Incentives, and Programs to Support the Approval of New Animal Drugs for Minor Uses and for Minor Species
  1. Search for FDA Guidance Documents

GUIDANCE DOCUMENT

CVM GFI #61 Special Considerations, Incentives, and Programs to Support the Approval of New Animal Drugs for Minor Uses and for Minor Species July 2020

Draft

Not for implementation. Contains non-binding recommendations.

This guidance is being distributed for comment purposes only.

Submit Comments by

Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the FDA considers your comment on a draft guidance before it begins work on the final version of the guidance, submit either online or written comments on the draft guidance before the close date.

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-1997-D-0444


Docket Number:
FDA-1997-D-0444
Issued by:
Guidance Issuing Office
Center for Veterinary Medicine

The Minor Use and Minor Species Animal Health Act of 2004 (commonly referred to as the “MUMS” Act) amended the FD&C Act to provide incentives to sponsors to develop “MUMS drugs,” that is, new animal drugs for use in minor species or for use in major species afflicted with uncommon diseases or conditions (minor uses), while ensuring appropriate safeguards for animal and human health.  

This guidance is intended to assist those interested in pursuing FDA approval of these new animal drugs. It outlines the basic requirements and special considerations for approvals of MUMs drugs and describes the incentives available to encourage their development.

Many of those seeking approval for MUMS drugs are new to the new animal drug approval process.  To better assist those who may be unfamiliar with the approval process, topics are presented in the order in which they commonly arise in the development of a MUMS drug.  Although FDA intends for this guidance to be generally useful for all parties that may pursue approval of a MUMS drug, some portions of this document contain information that applies specifically to applications for approval of MUMS drugs intended for use in aquatic species.

Questions?

Contact Point
Dr. Meg Oeller
Center for Veterinary Medicine
Food and Drug Administration
7500 Standish Place, HFV-50
Rockville, MD 20855
Back to Top