Drugs

Trial Speed Seen as Key to Accelerated Approvals

Three Hyman, Phelps & McNamara attorneys say the publication of FDA guidances on its new accelerated approval authorities in 12/2024 and 1/2025 provide a framework for how it plans to enforce its requirements that confirmatory trials for products receiving accelerated approval be “underway” and “conducted with due diligence.” Writing in their firm’s FDA Law Blog, the three say the guidances signal the agency’s intent to use authorities it was given in the Food and Drug Omnibus Reform Act of 2022 to ensure that clinical benefit be verified as quickly as possible and, if there is a concern a program will not verify benefit, to deny the initial accelerated approval.

“FDA has great discretion in what its expectations are for a study to be underway and conducted with due diligence,” the post says. “We now know that FDA can expect full enrollment of the study in some cases and merely expect initiation of enrollment in others.”

The post details the new authorities on the timely conduct of confirmatory trials as outlined in the two guidances.

The attorneys say FDA should be flexible in basing any adverse decisions on sponsors missing benchmarks and consider the factors included in the 12/2024 draft guidance on whether a study is being conducted with due diligence even from that early stage. “An agreement, a documented good faith effort, and open dialog between sponsors and the agency about such efforts and the difficulties encountered, we think, should carry significant weight in the short term to avoid regulatory action that may affect the availability of important treatments for patients,” they conclude.

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