New Animal Drugs; Approval of New Animal Drug Applications; Withdrawal of Approval of a New Animal Drug Application; Change of Sponsor
other · Food and Drug Administration · Rule · Published 2022-02-28 · Effective 2022-02-28 · 87 FR 10964
Document
Document number
2022-03538
Federal Register citation
87 FR 10964
CFR reference
21 CFR 500
Type
Rule
Action
Final rule; technical amendments.
Category
other
Sub-agency
Food and Drug Administration
Publication date
2022-02-28
Effective date
2022-02-28
HHS docket
Docket No. FDA-2021-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 a conditionally approved new animal drug application (cNADA) during July, August, and September 2021. 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 the accuracy of the regulations.