New Animal Drugs; Approval of New Animal Drug Applications; Changes of Sponsorship
other · Food and Drug Administration · Rule · Published 2016-04-18 · Effective 2016-04-18 · 81 FR 22520
Document
Document number
2016-08827
Federal Register citation
81 FR 22520
CFR reference
21 CFR 520
Type
Rule
Action
Final rule; technical amendment.
Category
other
Sub-agency
Food and Drug Administration
Publication date
2016-04-18
Effective date
2016-04-18
HHS docket
Docket No. FDA-2016-N-0002
Abstract
The Food and Drug Administration (FDA, 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 January and February 2016. FDA is also 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 reflect changes of sponsorship of applications that occurred in January and February.