New Animal Drugs; Approval of New Animal Drug Applications; Changes of Sponsorship
other · Food and Drug Administration · Rule · Published 2019-04-02 · Effective 2019-04-02 · 84 FR 12491
Document
Document number
2019-06136
Federal Register citation
84 FR 12491
CFR reference
21 CFR 510
Type
Rule
Action
Final rule; technical amendments.
Category
other
Sub-agency
Food and Drug Administration
Publication date
2019-04-02
Effective date
2019-04-02
HHS docket
Docket No. FDA-2018-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) and abbreviated new animal drug applications (ANADAs) during October, November, and December 2018. 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 make technical amendments to improve the readability of the regulations.