Drugs

HELP Committee Wants to Move FDA Legislation Forward: Alexander

Senate Health, Education, Labor and Pensions Committee chair Lamar Alexander (R-TN) says his committee is still planning to move forward its biomedical innovation/FDA reform bill despite the fact that it is a presidential election year. In remarks made before the HELP committee voted on Robert Califf’s nomination for FDA commissioner 1/12, Alexander said the committee and staff have worked hard on a medical product innovation measure over the past year.

“The staff have worked in a bipartisan way on three dozen pieces of legislation, which have significant democratic and republican support,” Alexander said. He said he is having discussions with ranking member Patty Murray (D-WA) about how the committee can move ahead on this. He acknowledged the House’s passage of the 21st Century Cures Act, saying that “there is never been a more exciting time in science and we should finish our work on this bill and I'm committed to doing it in a bipartisan way to allow amendments for consideration.”

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