This guidance describes the conditions under which applicants can use an alternative reporting format, the International Conference on 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 safety reporting requirements at 21 CFR 314.80(c)(2) and 600.80(c)(2).
This guidance uses the term applicant to mean the holder of an approved new drug application (NDA), abbreviated new drug application (ANDA), or biologics license application (BLA), which are referred to collectively in this guidance as applications. This guidance 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.
FDA’s guidance documents, including this guidance, do not establish legally enforceable responsibilities. Instead, guidances describe the Agency’s current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited. The use of the word should in Agency guidances means that something is suggested or recommended, but not required.