New Animal Drugs; Approval of New Animal Drug Applications; Withdrawal of Approval of New Animal Drug Applications; Changes of Sponsor; Change of Sponsor's Address
other · Food and Drug Administration · Rule · Published 2020-01-24 · Effective 2020-01-24 · 85 FR 4204
Document
Document number
2020-00421
Federal Register citation
85 FR 4204
CFR reference
21 CFR 510
Type
Rule
Action
Final rule; technical amendments.
Category
other
Sub-agency
Food and Drug Administration
Publication date
2020-01-24
Effective date
2020-01-24
HHS docket
Docket No. FDA-2019-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 July, August, and September 2019. 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.