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Postmarketing Safety Reports for Approved New Animal Drugs; Electronic Submission Requirements (Proposed Rule)

Postmarketing Safety Reports for Approved New Animal Drugs; Electronic Submission Requirements (Proposed Rule)

The Food and Drug Administration (FDA, Agency, or we) is proposing to amend its postmarketing safety reporting regulations for approved new animal drugs to require that certain adverse drug experience and product/manufacturing defect reports be submitted to FDA in an electronic format that we can process, review, and archive. This action is intended to improve our systems for collecting and analyzing postmarketing safety reports. The proposed change would help us to more rapidly review postmarketing safety reports, identify emerging safety problems, and disseminate safety information in support of our public health mission. In addition, the proposed amendments would facilitate international harmonization and exchange of safety information.

Regulatory Impact Analysis

Federal Register: 83 FR 6480, February 14, 2018
Docket: FDA-2017-N-6381-0001