Drugs

NIH Suspends Production in 2 Labs

The National Institutes of Health (NIH) says that an evaluation by two consulting firms ordered in response to serious problems identified by FDA in the NIH Clinical Center Pharmaceutical Development Section has led to suspension of production in two facilities. The evaluation looked at all facilities producing sterile or infused products for administration to research participants. The facilities found to be not complying with quality and safety standards and not suitable for producing sterile or infused products were a National Cancer Institute laboratory engaged in cell therapy production and a National Institute of Mental Health facility producing positron emission tomography materials.

“There is no evidence that any patients have been harmed,” NIH says, “but a rigorous clinical review will be undertaken. NIH will not enroll new patients in affected trials until the issues are resolved.”

A Clinical Center Working Group is to deliver 4/21 its report on an evaluation and recommendations about ways to enhance organization, financing, and management of the Clinical Center and its affiliated labs and production facilities.

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