Postmarketing Safety Reports for Approved New Animal Drugs; Electronic Submission Requirements
other · Food and Drug Administration · Rule · Published 2020-07-29 · Effective 2020-08-28 · 85 FR 45505
Document
Document number
2020-15441
Federal Register citation
85 FR 45505
CFR reference
21 CFR 514
Type
Rule
Action
Final rule.
Category
other
Sub-agency
Food and Drug Administration
Publication date
2020-07-29
Effective date
2020-08-28
HHS docket
Docket No. FDA-2017-N-6381
Abstract
The Food and Drug Administration (FDA, Agency, or we) is issuing a final rule to require electronic submission of certain postmarketing safety reports for approved new animal drugs. The final rule also provides a procedure for requesting a temporary waiver of the electronic submission requirement.