Drugs

Treatment Effects Higher in Accelerated Approvals: Study

A systematic review and meta-analysis conducted by researchers from several locations around the world found that the magnitude of treatment effects was some 2.5-fold higher among treatments that were approved based on non-randomized clinical trials (RCTs) than among treatments that required further testing in RCTs. Writing in an open source Journal of the American Medical Association article, the researchers say they found no clear threshold of magnitude of treatment effect above which FDA would not request further RCTs.

The researchers reviewed 606 drug applications for the Breakthrough Therapy designation and 71 medical device applications for the Humanitarian Device exemption.

They report finding that the quality of data on which FDA estimates the effects magnitude and eventually approval decisions is very low. “As inferences about treatment effects always rely on comparisons (direct or counterfactual), greater transparency about the basis for choosing (historical) comparators is needed to instill confidence that decisions about drug and device approval based on observational data are appropriate,” the researchers 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