Drugs

FDA Awards Drug Quality Research Grant to LIU

FDA has awarded a three-year $2 million grant to the Long Island University (LIU) Arnold and Marie Schwartz College of Pharmacy and Health Sciences to study variability in marketed drug products. The research initiative, “Building Towards Statistically-Based Pharmaceutical Quality Standards,” will focus on assessing the variability in some key non-clinical performance properties of a range of products. The university says that properties such as the rate at which tablets dissolve are key to ensuring that products can be manufactured to always perform as expected.

The grant will be shared with subcontractors at the Purdue University School of Chemical Engineering, where advanced statistical analysis will be used to jointly design and guide LIU’s experiments on how products perform in the laboratory. The findings will be used to generate statistical models to help better understand the design and manufacturing control needed for new drug products, the university says.

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