Drugs

FDA Holds Inaugural Roundtable on Talc in Products

FDA commissioner Marty Makary is announcing a 5/20 roundtable discussion of an independent panel of scientific experts to discuss the “safety and necessity of talc as an additive in food, drug, and cosmetic products.” This public roundtable, which will be livestreamed, will “follow a transparent process grounded in gold standard science, setting precedents for future discussions,” an agency notice says.

“The group, comprised of world-renowned experts in their respective fields, will review the latest scientific evidence, evaluate potential health risks, explore safer alternatives, and individual experts may offer their recommendations for regulatory action,” Makary said. “Despite the potential carcinogenic harm with topical talc, it continues to be ingested by children and adults through food and some medications. We are bringing together a group of leading independent experts to assess the available evidence around talc and consider whether its continued use is necessary given modern alternatives. This is a critical step toward ensuring that ingredients in products used every day by Americans meet the highest standards for safety.”

Makary says the roundtable initiative is part of the agency’s efforts to “apply rigorous, evidence-based standards to ingredient safety and modernize regulatory oversight, thoroughly considering evolving science and consumer health. In the coming weeks, the agency will announce additional FDA Expert Panel roundtables on a variety of topics.”

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