New Animal Drugs; Approval of New Animal Drug Applications; Changes of Sponsorship
other · Food and Drug Administration · Rule · Published 2021-10-20 · Effective 2021-10-20 · 86 FR 57992
Document
Document number
2021-22604
Federal Register citation
86 FR 57992
CFR reference
21 CFR 510
Type
Rule
Action
Final rule; technical amendments.
Category
other
Sub-agency
Food and Drug Administration
Publication date
2021-10-20
Effective date
2021-10-20
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 conditional new animal drug applications (cNADAs) during January, February, and March 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 and readability of the regulations.