FDA Policy/General

2 ICH Guidances on Periodic Benefit-Risk Evaluation

Federal Register Notice: FDA is making available two 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 Harmonization (ICH). The E2C(R2) draft guidance, issued 4/11/12, updated and combined two ICH guidances, E2C Clinical Safety Data Management: Periodic Safety Update Reports for Marketed Drugs (E2C guidance)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content, and timing of a Periodic Benefit-Risk Evaluation Report for an approved drug or biologic, and it finalizes the draft guidance.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. To download the E2C(R2) guidance, click here. To download the E2C(R2) Q&A guidance, click here. To view this notice, click here.

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FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome