Drugs

54% of Confirmatory Studies Are Late Meeting Deadlines

A JAMA research letter says 54% of the 177 accelerated approval-related confirmatory studies conducted between 2012 and 2021 were late in meeting their FDA completion deadlines. “Trials for nononcologic indications (93% [15 of 16]) were more likely to be late than those for oncologic indications (46% [39 of 84]),” the JAMA letter says. “Trials for small molecule drugs (62% [40 of 65]) were more likely to be late than those for biologics (40% [14 of 35]).”

The letter notes that missed confirmatory clinical trials completion deadlines harm patients who are prescribed expensive drugs despite uncertain clinical benefits. “However, drug manufacturers face few consequences for delays,” it says. The recent Consolidated Appropriations Act for 2023 included accelerated approval reforms (FDA authority to require that confirmatory trials are under way before approval, progress reports every six months by manufacturers, and quicker procedures for withdrawing drugs that fail such studies). “It will be important to monitor whether these changes lead to fewer delays or whether additional authority is needed to assure that confirmatory trials are completed in a timely manner for the benefit of patients,” the letter 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

Read more

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