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FDA Issues Final Guidance on Electronic Postmarketing Safety Reports

May 3, 2022


FDA has issued the final guidance, Providing Submissions in Electronic Format– Postmarketing Safety Reports, the last in a series of guidance documents intended to assist industry when making certain regulatory submissions in electronic format to FDA’s Center for Drug Evaluation and Research (CDER) and Center for Biologics Evaluation and Research (CBER).

The guidance is intended for any party with postmarketing safety reporting responsibilities for approved and unapproved human drug products and licensed biological products, excluding vaccines. The guidance also provides recommendations on how to submit postmarketing safety reports that FDA can process, review, and archive. A revised draft version of this guidance was issued in June 2014, and minimal changes were made in the final guidance.

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