Drugs

CDER Adds Cannabis Advisor in Director’s Office

Former New York cannabis programs director Norman Birenbaum has joined CDER’s Office of the Center Director as a senior public health advisor “responsible for advancing our efforts related to research and regulation of cannabis as a part of CDER’s work in controlled substances,” according to deputy Center director Douglas Throckmorton.

Previously, Birenbaim served as the chief cannabis policy advisor for Rhode Island and led the agencies responsible for cannabis regulation and research there and in New York. In New York, his work there “culminated in the successful 2021 passage of the Marijuana Regulation and Taxation Act, which legalized cannabis for adult use in New York and created a consolidated Office of Cannabis Management to oversee all cannabis sectors within the state,” Throckmorton says.

Earlier in his professional career, he was the founding president of the Cannabis Regulators Association, whose members represent the primary cannabis regulatory agencies from 43 states and U.S. territories across the country. He graduated from Boston College with a bachelor’s degree in political science.

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