Drugs

FDA Touts CDER Advanced Manufacturing Research Facility

FDA says CDER’s new Advanced Manufacturing Research Facility is “a new laboratory for evaluating innovative drug manufacturing technologies and ensuring drugs produced with the technologies are safe, effective, and high-quality.” An online post says CDER uses this facility to lead regulatory science research for current and new advanced manufacturing technologies and strengthen the agency’s connection between research, policy, and assessment.

The 18,000-square foot state-of-the-art research space has a flexible design so it can be reconfigured rapidly as needed to research regulatory science priorities, FDA says.

The facility includes a multi-use laboratory for various research needs, an analytical testing laboratory for rigorous evaluation and testing, and specialized laboratories focused on understanding the impact of emerging manufacturing technologies on the quality of solid oral dosage forms, complex drug products, active pharmaceutical ingredients, and biotechnology processes.

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