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GUIDANCE DOCUMENT

CVM GFI #261 - Eligibility Criteria for Expanded Conditional Approval of New Animal Drugs September 2019

Draft

Not for implementation. Contains non-binding recommendations.

Docket Number:
FDA-2019-D-3361
Issued by:
Guidance Issuing Office
Center for Veterinary Medicine

This guidance is intended for sponsors and potential sponsors interested in pursuing conditional approval of new animal drugs for certain major uses in major species.

In 2018, Congress enacted legislation reauthorizing FDA’s animal drug user fee program for an additional 5 years (ADUFA IV).  This legislation also amended section 571 of the Federal Food, Drug, and Cosmetic Act to include provisions for expanded conditional approval of new animal drugs.  Eligibility for conditional approval has been expanded beyond minor uses in major species and use in minor species (MUMS) to also include certain major uses in major species in order to incentivize development of new animal drugs for serious or life-threatening conditions or unmet animal or human health needs where demonstration of effectiveness would require a complex or particularly difficult study or studies.

The Center for Veterinary Medicine refers to the process for conditionally approving new animal drugs that are not MUMS drugs as “expanded conditional approval.”  This guidance defines certain terms, clarifies the eligibility criteria for expanded conditional approval, and describes the criteria CVM intends to consider when determining expanded conditional approval eligibility.


Submit Comments

You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))

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-2019-D-3361.

Questions?

Contact Point
Christopher Loss
Center for Veterinary Medicine
Food and Drug Administration
7500 Standish Place, HFV-116
Rockville, MD 20855
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