title: E2C(R2) Periodic Benefit-Risk Evaluation Report and E2C(R2)   Periodic Benefit-Risk Evaluation Report--Questions and Answers;   International Council for Harmonisation; Guidances for Industry;   Availability. Notice.
abstract: The Food and Drug Administration (FDA or Agency) is announcing the availability of guidances for industry entitled ``E2C(R2) Periodic Benefit-Risk Evaluation'' (E2C(R2) guidance) and ``E2C(R2) Periodic Benefit-Risk Evaluation Report--Questions and Answers'' (E2C(R2) Q&A guidance). These guidances were prepared under the auspices of the International Council for Harmonisation (ICH), formerly the International Conference on Harmonisation. The E2C(R2) draft guidance, issued April 11, 2012, updated and combined two ICH guidances, ``E2C Clinical Safety Data Management: Periodic Safety Update Reports for Marketed Drugs'' (E2C guidance) and ``Addendum to E2C Clinical Safety Data Management: Periodic Safety Update Reports for Marketed Drugs'' (addendum to the E2C guidance). The E2C(R2) guidance is intended to describe the format, content, and timing of a Periodic Benefit-Risk Evaluation Report (PBRER) for an approved drug or biologic, and it finalizes the draft guidance. The E2C(R2) Q&A guidance is a supplementary guidance that is intended to clarify key issues in the E2C(R2) guidance.
mesh_terms: D002170:Canada; D003226:Congresses as Topic; D003362:Cost-Benefit Analysis / Q000592:standards*; D017277:Drug Approval; D004345:Drug Industry / Q000592:standards*; D005060:Europe; D017408:Guidelines as Topic; D006801:Humans; D007391:International Cooperation; D007564:Japan; D011358:Product Surveillance, Postmarketing / Q000592:standards*; D014481:United States; D014486:United States Food and Drug Administration