Devices

Bill to Block LDT Regulation

Reps. Brad Finstad (R-MN) and Dan Crenshaw (R-TX) have introduced the Freedom for Laboratory Innovation and Testing Act to block FDA from regulating laboratory-developed tests (LDTs). The representatives also wrote to HHS secretary Robert Kennedy asking that he revoke the FDA rule that was adopted during the Biden administration.

In a statement (includes a link to the letter to Kennedy), Finstad said the FDA rule would:

impose regulatory burdens that would hinder the development of new and improved LDTs;
increase regulatory requirements that would lead to delays in patients’ access to critical diagnostic tests;
potentially hinder collaborative efforts in clinical care that rely on the flexibility provided by LDTs; and
negatively affect small- and medium-sized laboratories, which would face economic challenges in complying with the rule as written.

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