CVM GFI #61 FDA Approval of New Animal Drugs for MUMS
The purpose of this document is to suggest means of generating effectiveness and safety data to support the approval of minor use animal drugs. A minor animal drug use is defined as use in a minor species OR use in any animal species for a condition that is rare or that occurs in limited geographic areas. Minor species are defined by exclusion, as any species other than major species. Major species are defined as cattle, swine, chickens, turkeys, horses, dogs, and cats. According to current regulations, sheep are a minor species except with respect to human food safety data collection requirements, for which sheep are considered major species. VM intends to issue a proposed regulation in which sheep would be defined as a minor species for all requirements of the drug approval process. Other guidance addresses issues relating to exotic and wildlife species.
CVM currently considers veal calves separately from cattle for the drug approval process. Thus, portions of this guidance document relating to ‘Domestic and Semi-Domestic Minor Ruminants’ may prove useful with respect to supporting indications for use in veal calves.
Submit comments on this guidance document electronically via docket ID: FDA-2013-S-0610 - Specific Electronic Submissions Intended For FDA's Dockets Management Staff (i.e., Citizen Petitions, Draft Proposed Guidance Documents, Variances, and other administrative record submissions)
If unable to submit comments online, please mail written comments to:
Division of Dockets Management (HFA- 305)
Food and Drug Administration
5630 Fishers Lane, Rm. 1061
Rockville, MD 20852
All comments should be identified with the title of the guidance.