Devices

Senators Quiz FDA on Hand Sanitizers

U.S. senators Joni Ernst (R-IA) and Chuck Grassley (R-IA) have sent a letter to FDA asking for clarification on its temporary policy for manufacturing alcohol-based hand sanitizer products during the Covid-19 pandemic. In March, the agency released a temporary guidance on ethanol used in hand sanitizer production, which permitted biofuel manufacturers to produce alcohol for hand sanitizer. However, the senators wrote, on 4/15 FDA revised the guidance, which left many in the industry unclear of what standards need to be met.

“As more of the economy gets reopened, the need for hand sanitizer at schools, restaurants, churches, factories, and other locations will continue to grow, they wrote. “While the FDA has taken action to prevent a potential shortage, further clarification is needed to help businesses have certainty on the future of hand sanitizer manufacturing. While understanding the need for safe, effective, and affordable hand sanitizer for our country, we ask that you immediately review your risk analysis and criteria for evaluating samples of ethanol from renewable fuel manufacturers.”

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