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Postmarketing Safety Reports for Human Drug and Biological Products: Electronic Submission Requirements

Abstract: The final rule would amend FDA's postmarketing safety reporting regulations for human drug and biological products to require that mandatory safety reports submitted to the Agency be transmitted in an electronic format that FDA can process, review, and archive. The rule will allow the Agency to review safety reports more quickly, to identify emerging safety problems, and disseminate safety information more rapidly in support of FDA's public health mission. The amendments also would be a key element in harmonizing FDA's postmarketing safety reporting regulations with international and International Harmonization Standards standards for the electronic submission of safety information.
RIN: 0910-AF96
Type: Rule Making
Docket Item Code N
Center CDER

7 Comments