FDA Policy/General

Sen. Schumer Calls for FDA Probe on Sunscreens

Senator Charles Schumer (D-NY) has urged FDA to launch an investigation into deceptive sun protection factor (SPF) marketing, following a study released by Consumer Reports which suggests that 43% of sunscreen products fail to meet the SPF claim on the label. “There is simply no doubt about it—some consumers are being totally burned when they buy sunscreen, which is why the FDA must give sunscreen labels the third degree,” Schumer said in a statement. Currently, FDA only requires manufacturers test its sunscreen products and does not require manufacturers to submit results to the agency.

Schumer is also urging FDA to finalize sunscreen rules that were created based on 2014-passed legislation, the Sunscreen Innovation Act. Schumer said the agency has been “dragging its feet in their testing of ultra-effective sunscreen ingredients that better protects individuals from sunburn and skin cancer. The FDA has been reviewing some of these ingredients for over a decade, and the superior sunscreens are available in almost every other country in the world.”

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