Drugs

CDER Policy Chief Axelrad Retiring After 25 Years at FDA

After 25 years at FDA, CDER associate director for policy Jane Axelrad will retire effective 4/29. In total, she has 41 years of government service when counting legal and policy positions she held at the Nuclear Regulatory Commission and the Environmental Protection Agency prior to joining the agency in 1991.

Currently, Axelrad has served as the agency’s lead on drug compounding following the 2012 fungal meningitis outbreak. In that capacity, she led negotiations related to the enactment of the compounding provisions in the 2013 Drug Quality and Security Act. Additionally, she was one of the principal negotiators of the Prescription Drug User Fee Act reauthorizations over the past 20 years.

FDA Office of Chief Counsel attorney Julie Dohm has agreed to come to CDER on a detail to lead the drug compounding initiative. She has a law degree from the University of Pennsylvania Law School and a doctoral degree in biology from Johns Hopkins University. While at the agency, Dohm has worked on compounding litigation, as well as the drugs counseling team.

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