Drugs

FDA Releases Revised ICH Efficacy Format Guidance

FDA has issued a revised International Council for Harmonization guidance on “M4E(R2): The CTD — Efficacy.” The document provides recommendations for applicants preparing the Common Technical Document (CTD) for submissions to the agency. It presents the agreed-upon common format that will be accepted in the ICH regulatory regions for the preparation of a well-structured Efficacy section of the CTD, the document says.

This guidance mainly addresses the information organization contained in the efficacy section of an application for new pharmaceuticals or biologics and “indicates an appropriate format for the data that have been acquired,” FDA says. “Applicants should not modify the overall organization of the CTD. However, in the Nonclinical and Clinical Summaries sections of the CTD, applicants can modify individual formats, if needed, to provide the best possible presentation of thetechnicalinformation to facilitate the understanding and evaluation of the results.”

Gupta Raises Concerns About Overton’s Independence, Ideology

FDA commissioner nominee Heidi Overton’s responses on vaccines, contraception and abortion medication during her 9/24 Senate confirmation hearing raise concerns that ideology could influence her decision-making if she takes over the agency, MSNBC senior medical analyst Dr. Vin Gupta said Friday. Gupta was particularly critical of Overton’

Overton Confirmation Remains Uncertain After Senate Hearing

FDA commissioner nominee Heidi Overton emerged from her Senate confirmation hearing Thursday (see earlier story) without resolving questions about whether she has enough Republican support to advance — and with a rapidly narrowing window for confirmation before the midterm elections. The Senate Health, Education, Labor and Pensions Committee hearing provided few

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA has classified Boston Scientific's recall of its Imager II Angiographic Catheters as Class I because a manufacturing problem could cause catheter tips to degrade and detach, potentially resulting in life-threatening complications. The agency announced the Class I classification 9/25, updating an Early Alert it issued

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

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