New Animal Drugs; Approval of New Animal Drug Applications; Withdrawal of Approval of New Animal Drug Applications; Changes of Sponsorship
other · Food and Drug Administration · Rule · Published 2017-05-10 · Effective 2017-05-10 · 82 FR 21688
Document
Document number
2017-09364
Federal Register citation
82 FR 21688
CFR reference
21 CFR 510
Type
Rule
Action
Final rule; correcting amendments.
Category
other
Sub-agency
Food and Drug Administration
Publication date
2017-05-10
Effective date
2017-05-10
HHS docket
Docket No. FDA-2017-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 January and February 2017. 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 several changes of sponsorship of applications and to make correcting amendments to improve the accuracy of the regulations.