New Animal Drugs; Approval of New Animal Drug Applications
other · Food and Drug Administration · Rule · Published 2017-12-13 · Effective 2017-12-13 · 82 FR 58554
Document
Document number
2017-26753
Federal Register citation
82 FR 58554
CFR reference
21 CFR 510
Type
Rule
Action
Final rule; technical amendments.
Category
other
Sub-agency
Food and Drug Administration
Publication date
2017-12-13
Effective date
2017-12-13
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 a new animal drug application (NADA) and abbreviated new animal drug applications (ANADAs) during May and June 2017. 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 accuracy of the regulations.