Drugs

Rep. Pallone Introduces Drug Continuous Manufacturing Bill

Rep. Frank Pallone, Jr. (D-NJ) has introduced the National Centers of Excellence in Continuous Manufacturing Act of 2018, which would allow FDA to partner with universities across the country to designate them as National Centers of Excellence in Continuous Pharmaceutical Manufacturing. He announced the bill’s introduction during a 4/16 visit with FDA commissioner Scott Gottlieb to Rutgers University to tour the school’s Center for Structured Organic Particulate Systems (C-SOPS) and discuss the center’s role in advancing continuous manufacturing for drug products. The designated universities would work with FDA and industry to further develop and implement continuous manufacturing technology. The legislation would also authorize $80 million in funding to support the effort.

Pallone notes that Rutgers’ C-SOPS has been in place for over a decade and has designed and implemented continuous manufacturing methods for powder-based pharmaceutical products. The center is working side-by-side with industry to integrate continuous manufacturing into commercial production, the Pallone statement says.

Continuous manufacturing is an emerging technology where finished products are produced in a continuous stream. It allows quality to be precisely controlled, and reduces challenges when scaling up commercial production.

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