Drugs

FDA to Permit In-Person End-of-Phase 2 Meetings

FDA continues to ramp up its return to face-to-face (FTF) meetings and beginning 6/12 CDER and CBER will expand in-person FTF industry meetings to include requests for Type B End-of-Phase 2 requests. The End-of-Phase 2 requests join the previously announced Type A, BPD Type 1, and Type X meeting requests, according to a new notice. Type A meetings are those that are necessary for a stalled drug development program to proceed. A BPD Type 1 meeting is a meeting that is necessary for a stalled biosimilar product development program to proceed. And a Type X meeting is necessary for an otherwise stalled OTC monograph development program to proceed.

“FTF meeting requests for other meeting types, if granted, will be held fully virtually (i.e., the in-person format will not be considered),” the agency says. Existing meeting requests filed before 6/12/2023 or meetings already scheduled regardless of the scheduled meeting date, “will not be converted to the in-person format, to permit fair implementation of the transition,” it says.

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