FDAnews Drug Daily Bulletin

FDA Clarifies Steps for Sponsors to Submit Alternative ICH Postmarket Reports

Dec. 5, 2016

Drug sponsors hoping to submit an alternative postmarket report, known as the periodic benefit-risk evaluation report (PBRER), at a different frequency than required should plan to file a waiver request, the FDA said.

In a final guidance, the FDA explains when sponsors who have an ICH format waiver will have to submit a new waiver request or notification to the FDA. The waiver requests and notifications would cover reporting frequency, data lock points or submission intervals.

A draft version of the guidance did not distinguish between amendments requiring notifications and the ones needing new waiver requests. Instead, all sponsors were advised to file notifications that ensured frequency requirements are being met for postmarket reports.

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