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HHS/FDA | RIN: 0910-AI18 | Publication ID: Fall 2019 |
Title: Conditional Approval of New Animal Drugs | |
Abstract:
FDA is issuing procedural regulations for conditional approval of new animal drugs under the conditional approval provisions of the Federal Food, Drug, and Cosmetic Act. The new regulations are intended to make more medications legally available to veterinarians and animal owners. A sponsor can apply for conditional approval of a new animal drug based on certain criteria, which allows the sponsor to make the drug available before collecting all necessary effectiveness data, but after demonstrating the drug is safe in accordance with the full FDA approval standard and showing that there is a reasonable expectation of effectiveness. The drug sponsor can keep the product on the market for up to 5 years, through annual renewals, while collecting the remaining required effectiveness data. |
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Agency: Department of Health and Human Services(HHS) | Priority: Substantive, Nonsignificant |
RIN Status: Previously published in the Unified Agenda | Agenda Stage of Rulemaking: Proposed Rule Stage |
Major: No | Unfunded Mandates: Undetermined |
EO 13771 Designation: Deregulatory | |
CFR Citation: 21 CFR 516 | |
Legal Authority: 21 U.S.C. 360ccc 21 U.S.C. 371(a) |
Legal Deadline:
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Timetable:
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Regulatory Flexibility Analysis Required: No | Government Levels Affected: None |
Small Entities Affected: Businesses | Federalism: No |
Included in the Regulatory Plan: No | |
RIN Data Printed in the FR: No | |
Agency Contact: Urvi Desai Supervisory Regulatory Counsel Department of Health and Human Services Food and Drug Administration Center for Veterinary Medicine, 7500 Standish Place, MPN-2, HFV-101, Rockville, MD 20855 Phone:240 402-0689 Email: urvi.desai@fda.hhs.gov |