New Animal Drugs; Approval of New Animal Drug Applications; Withdrawal of Approval of New Animal Drug Applications
other · Food and Drug Administration · Rule · Published 2023-05-03 · Effective 2023-05-03 · 88 FR 27693
Document
Document number
2023-09212
Federal Register citation
88 FR 27693
CFR reference
21 CFR 510
Type
Rule
Action
Final rule; technical amendments.
Category
other
Sub-agency
Food and Drug Administration
Publication date
2023-05-03
Effective date
2023-05-03
HHS docket
Docket No. FDA-2023-N-0002
Abstract
The Food and Drug Administration (FDA or we) is amending the animal drug regulations to reflect application-related actions for new animal drug applications (NADAs), abbreviated new animal drug applications (ANADAs), and conditionally approved new animal drug applications (cNADAs) during January, February, and March 2023. FDA is informing the public of the availability of summaries of the basis of approval and of environmental review documents, where applicable. The animal drug regulations are also being amended to improve their accuracy and readability.