Drugs

Over 1,500 Companies Register to Produce Hand Sanitizer

FDA says that over 1,500 additional manufacturers have registered with the agency to produce hand sanitizer. An agency statement says it also is addressing safety concerns related to products being sold that are not in line with agency policy and others being marketed with unproven claims.

The statement says the agency has received feedback and questions recently about the need to use denatured alcohol for the products. It notes that adding denaturants to the alcohol renders the product more bitter and less appealing to ingest, particularly for young children.

“While the agency understands the economic and business reasons behind foregoing this step in the manufacturing process, such an approach undermines the agency’s mission of helping to ensure the safety of FDA-regulated products for consumer use,” FDA says. “This approach is consistent with FDA’s policies prior to the Covid-19 pandemic on including denatured alcohol in hand sanitizer and is even more important now as more consumers rely on its use as a mitigation tool against the deadly virus.”

The statement also says the agency is concerned about hand sanitizer products being sold by some manufacturers during the Covid-19 pandemic with unproven claims.

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