Drugs

Emergent Recalls Skin Decontamination Lotion

Emergent has recalled certain Reactive Skin Decontamination Lotion (RSDL) kits from a specific batch based on customer complaints about some packets leaking. An FDA recall notice says each kit contains a sponge soaked with lotion, and they are intended for military use to remove or neutralize chemical warfare agents and T-2 Toxin from the skin. To date, there have been three complaints and no reported adverse events.

“In a situation of exposure to chemical warfare agents or T-2 toxin requiring immediate decontamination with RSDL, the potential for reduced or absent device effectiveness could make the exposed individual vulnerable to health hazards from the chemical agent exposure,” the notice says. “Additionally, unnecessary exposure to the non-opened packets that have been contaminated by the lotion from the leaked packets could result in unintentional prolonged skin, eyes, and mucous membrane exposure to the military personnel as well as unsuspecting handlers of the subject RSDL kits.”

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