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

概要

The Food and Drug Administration (FDA) is correcting a final rule entitled "Postmarketing Safety Reports for Human Drug and Biological Products; Electronic Submission Requirements" that appeared in the Federal Register of June 10, 2014 (79 FR 33072). The document amended FDA's 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. The document was published with incorrect information regarding the availability of the International Conference on Harmonization's (ICH) data elements for postmarketing safety reports. The document also published with an incorrect statement regarding the impact of the final rule on small entities. This document corrects those errors.