Nonserious postmarket adverse event report waivers may be sought by firms, FDA says.
This article was originally published in The Tan Sheet
Executive Summary
NONSERIOUS POSTMARKETING ADVERSE EVENT REPORT WAIVERS may be sought by manufacturers for drugs, such as Rx-to-OTC switches, and some biologics, FDA indicates in a clarification of agency adverse event reporting requirements. "FDA is willing to entertain waiver requests for periodic submission of individual case reports for adverse experiences that are determined to be nonserious and labeled," an Aug. 27 agency guidance states.