federal_register: 2013-08014

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2013-08014 Draft Guidance for Industry on Providing Postmarket Periodic Safety Reports in the International Conference on Harmonisation E2C(R2) Format (Periodic Benefit-Risk Evaluation Report); Availability Notice The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled "Providing Postmarket Periodic Safety Reports in the ICH E2C(R2) Format (Periodic Benefit-Risk Evaluation Report)." This guidance 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 Harmonisation (ICH) E2C(R2) Periodic Benefit-Risk Evaluation Report (PBRER) in place of the ICH E2C(R1) Periodic Safety Update Report (PSUR), U.S. periodic adverse drug experience report (PADER), or U.S. periodic adverse experience report (PAER), to satisfy the periodic safety reporting requirements in FDA regulations. The guidance describes the steps applicants can take to submit the PBRER, and discusses the format, content, submission deadline, and frequency of reporting for the PBRER. 2013-04-08 2013 4 https://www.federalregister.gov/documents/2013/04/08/2013-08014/draft-guidance-for-industry-on-providing-postmarket-periodic-safety-reports-in-the-international https://www.govinfo.gov/content/pkg/FR-2013-04-08/pdf/2013-08014.pdf Health and Human Services Department; Food and Drug Administration 221,199 The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled "Providing Postmarket Periodic Safety Reports in the ICH E2C(R2) Format (Periodic Benefit-Risk Evaluation Report)." This guidance is...  

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