New Animal Drugs; Approval of New Animal Drug Applications; Changes of Sponsorship; Change of a Sponsor's Name and Address
other · Food and Drug Administration · Rule · Published 2018-12-18 · Effective 2018-12-18 · 83 FR 64738
Document
Document number
2018-27238
Federal Register citation
83 FR 64738
CFR reference
21 CFR 510
Type
Rule
Action
Final rule; technical amendments.
Category
other
Sub-agency
Food and Drug Administration
Publication date
2018-12-18
Effective date
2018-12-18
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 April, May, and June 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 accuracy and readability of the regulations.