Devices

FDA Lab Test Proposal is ‘Double Regulation’: Senator

Sen. Lamar Alexander (R-TN) says that an FDA proposal to regulate laboratory-developed tests amounts to “double regulation” since the tests are already regulated by the Centers for Medicare and Medicaid Services through the Clinical Laboratories Improvement Act. At a Senate Health Committee hearing on the proposal, Alexander said “the biggest loser, it seems to me, would be Americans who stand to benefit from the rapid pace of science and discovery.”

He cited an example from Vanderbilt University, which he says performs 105 “medical tests designed, manufactured, and used in a single laboratory.” Making even one of those tests subject to FDA approval, he said, could cost Vanderbilt $30 to $75 million to go through the process. “You can see how quickly costs could add up, even into the billions,” Alexander added.

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