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

Resumen

The Food and Drug Administration (FDA) is proposing to amend its postmarketing safety reporting regulations for human drug and biological products to require that persons subject to mandatory reporting requirements submit safety reports in an electronic format that FDA can process, review, and archive. FDA is taking this action to improve the agency's systems for collecting and analyzing postmarketing safety reports. The proposed change would help the agency to more rapidly review postmarketing safety reports, identify emerging safety problems, and disseminate safety information in support of FDA's public health mission. In addition, the proposed amendments would be a key element in harmonizing FDA's postmarketing safety reporting regulations with international standards for the electronic submission of safety information.