Business · 08/09/2014

FDA Corrects Final Rule on Postmarketing Safety Reports for Human Drug and Biological Products

The Food and Drug Administration (FDA) is correcting a final rule regarding postmarketing safety reports for human drug and biological products, which was published with an incorrect RIN number in the Federal Register on June 10, 2014. The rule now requires electronic submissions for safety reports that the FDA can process, review, and archive.