Drugs

FDA, TransCelerate Collaborate on Streamlined Safety Data Collection

FDA and TransCelerate are reporting highlights from a recent joint tabletop exercise in which the CDER Center for Clinical Trial Innovation and the nonprofit focused on how to streamline the collection of safety data, which TransCelerate says is an essential step in scaling the use of pragmatic elements in clinical trials. Selective Safety Data Collection (SSDC) is described as a risk-based approach reflected in the International Council for Harmonization’s guidance and emerging regulatory frameworks, and is the subject of an FDA White Paper (a link is in the TransCelerate statement).

“This exercise explored how SSDC can be applied in practice while maintaining patient safety and data integrity,” the statement says. The late 2025 exercise convened more than 20 pharmaceutical research and development leaders from TransCelerate and its member companies, with more than 15 FDA representatives.

The statement contains a link to the public summary of the 2025 tabletop exercise.

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