Drugs

FDA Guidance on Drug Periodic Safety Reports

FDA has released a guidance on “Providing Postmarketing Periodic Safety Reports in the ICH E2C(R2) Format (Periodic Benefit-Risk Evaluation Report)” that describes the conditions under which applicants can use an alternative reporting format, the International Council for Harmonization (ICH) E2C(R2) Periodic Benefit-Risk Evaluation Report (PBRER), in place of the agency’s periodic adverse drug experience report (PADER), U.S. periodic adverse experience report (PAER), or ICH E2C Periodic Safety Update Report (PSUR), to satisfy postmarketing safety reporting requirements. The document also describes the procedures applicants should follow if they wish to submit a PBRER in place of a PADER, PAER, or PSUR. “The steps will differ, depending on whether or not the applicant has an approved waiver in place to substitute the PSUR for the PADER/PAER,” it says.

FDA Guidance on Drug Periodic Safety Reports

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