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  1. Economic Impact Analyses of FDA Regulations

Postmarketing Safety Reports for Approved New Animal Drugs; Electronic Submission

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.

Regulatory Impact Analysis

Postmarketing Safety Reports for Approved New Animal Drugs; Electronic Submission Requirements (Final Rule) (PDF - 249KB)

Federal Register: 21 CFR Part 514, July 29, 2020

Docket: FDA-2017-N-6381

 

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