Drugs

Accelerated Approval On- and Off-Ramp Approaches

Staff in the FDA Oncology Center of Excellence say new procedures are needed for oncology drug accelerated approvals to shorten the time between approval and the completion of a confirmatory study. “The time between accelerated approval and verification or refutation of clinical benefit is a period of uncertainty,” the staffers write in the New England Journal of Medicine. “The pathway’s success should be measured in part by the length of this period…. Public discussion has focused on improving the accelerated approval off-ramp, suggesting specific time limits for completing confirmatory trials, patient enrollment milestones for evaluating timely trial completion, and alternative procedures for withdrawing indications. But equally important are procedures to build quality and efficiency into the accelerated approval on-ramp, which should include a prospective comprehensive strategy detailing plans for accelerated approval and the verification of clinical benefit, with the aim of expanding therapeutic advances and shortening this period of uncertainty.”

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