Devices

Cassidy Wants Test Regulation Ideas

Sen. Bill Cassidy (R-LA), who says FDA is exceeding its legislative authority in seeking to reform clinical test regulation through rulemaking, is asking stakeholders for their ideas on how Congress can modernize current regulations to support innovation and ensure the tests are safe and effective to use. In an open letter, Cassidy says past congressional efforts to reform the regulation of diagnostics have been unsuccessful, resulting in missed opportunities to implement substantive updates to the regulatory frameworks for laboratory services and diagnostic products.

He asks “interested parties” to respond by 4/3 to 21 questions on the FDA regulatory framework for diagnostics and the 1988 Clinical Laboratory Improvement Amendments regulatory framework for laboratory-developed tests.

“Clinical tests are essential healthcare resources, informing 70% of all clinical decisions through diagnosis, screening, staging, and managing of diseases and medical conditions,” Cassidy writes. “Since 1976, there have been no significant reforms to the regulation of clinical tests, even as new, innovative tests are being used in healthcare settings.”

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