New Animal Drugs; Approval of New Animal Drug Applications; Withdrawal of Approval of a New Animal Drug Application; Change of Sponsor; Change of Sponsor's Name
other · Food and Drug Administration · Rule · Published 2017-03-01 · Effective 2017-03-01 · 82 FR 12167
Document
Document number
2017-03930
Federal Register citation
82 FR 12167
CFR reference
21 CFR 510
Type
Rule
Action
Final rule; technical amendment.
Category
other
Sub-agency
Food and Drug Administration
Publication date
2017-03-01
Effective date
2017-03-01
HHS docket
Docket No. FDA-2016-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 November and December 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 the change of sponsorship of an application and a change of a sponsor's name.