Federal Register Notice: FDA is making available a draft guidance, Providing Postmarket Periodic Safety Reports in the ICH E2C(R2) Format (Periodic Benefit-Risk Evaluation Report). It is intended to inform applicants of the conditions under which FDA will exercise its waiver authority to permit applicants to submit an International Conference on Harmonization E2C(R2) Periodic Benefit-Risk Evaluation Report in place of the ICH E2C(R1) Periodic Safety Update Report, U.S. periodic adverse drug experience report, or U.S. periodic adverse experience report to satisfy the periodic safety reporting requirements in FDA regulations. To download this draft guidance, click here. To view this notice, click here.