Drugs

Bayesian Demo Project Explained

FDA says the CDER Center for Clinical Trial Innovation’s Bayesian Statistical Analysis demonstration project supports the goal of increasing the use and understanding of Bayesian statistical methods in simple clinical trial settings across sponsors, CDER clinical reviewers, and CDER statisticians. An online post says the demonstration provides a structured opportunity to use Bayesian approaches for the pre-specified primary analysis, supplementary analysis, or monitoring of simple trials such as those with a non-adaptive or straightforward sequential design.

The notice says that participating in the demonstration project gives sponsors additional CDER support to align on the statistical analysis plan, ensuring it robustly supports drug safety and efficacy evaluations while improving trial efficiency. “The project fosters collaboration with FDA/CDER subject matter experts in Bayesian statistics, encouraging knowledge exchange and methodological refinement,” it says.

Instructions on submitting a proposal are here.

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