Drugs

FDA Role in Medical Isotope Development

The U.S. now has a sufficient supply of molybdenum-99 (Mo-99) produced without highly enriched uranium, thanks to efforts by FDA and other government and private organizations. In a CDER From Our Perspective online post, Division of Imaging and Radiation Medicine medical officer Joseph Rajendran says the Center has been working to shift the production of medical isotopes from highly enriched uranium (which can be diverted and used to create weapons) to low enriched uranium and non-uranium sources.

“CDER’s role is to advance innovative technologies for increasing domestic production by providing expert advice during the development phase of the product and assessing the quality of the product prior to approval and during the post-marketing phase,” Rajendran says. “FDA nuclear chemists, microbiologists, engineers, and a broad range of scientists and medical professionals from both CDER and CDRH provided important scientific and technical expertise throughout the development of this innovative technology.”

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

Read more

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