Drugs

FDA Acts to Increase Sanitizer Supply, Control Carcinogens

FDA commissioner Stephen Hahn says the agency has updated guidances to provide additional clarification on the manufacturing and compounding of certain alcohol-based hand sanitizer products to help ensure that harmful levels of impurities are not present in ethanol used in the hand sanitizer products. “FDA appreciates industry’s willingness to help meet the increasing demand for alcohol-based hand sanitizers during the Covid-19 pandemic,” Hahn says. “Early on during the public health emergency, as demand for alcohol-based hand sanitizer had dramatically increased, we issued temporary policies to provide flexibility to help meet this demand and to help get supply quickly to where it was needed, whether it was for healthcare professionals or for individuals and their families.”

The statement says FDA is working with industry to ensure that harmful levels of impurities are not present if ethanol is used in the sanitizers. Its guidance update specifies interim levels of certain impurities that FDA has determined can be tolerated for a relatively short period of time, “given the emphasis on hand hygiene during the Covid-19 public health emergency and to avoid exacerbating access issues for alcohol-based hand sanitizer.”

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