Postmarketing adverse event report waivers may be sought for nonserious labeled side effects -- FDA.
FDA READY TO WAIVE NONSERIOUS POSTMARKETING ADVERSE EVENT REPORTING for drugs and some biologics, the agency indicated in a clarification of its 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," the guidance states.
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