This guidance describes the conditions under which applicants can use an alternative reporting format, the International Council for Harmonisation (ICH) E2C(R2) Periodic Benefit-Risk Evaluation Report (PBRER), in place of the U.S. periodic adverse drug experience report (PADER), U.S. periodic adverse experience report (PAER), or ICH E2C Periodic Safety Update Report (PSUR), to satisfy the periodic postmarketing safety reporting requirements in §§ 314.80(c)(2) and 600.80(c)(2) (21 CFR 314.80(c)(2) and 600.80(c)(2)). This guidance 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.


Posted on the FDA website on 28 November 2016