Drugs

FDA Looking at Marijuana Scheduling Flexibility: Woodcock

FDA principal deputy commissioner Janet Woodcock told a Council for Federal Cannabis Regulation Webinar that the agency is exploring what flexibilities it might have as part of President Biden’s order for a marijuana scheduling review. But Woodcock cautioned that while FDA will lead the scientific and medical evaluation of cannabis, it is the Drug Enforcement Administration that makes the final scheduling decisions, according to an online Marijuana Moment post.

The post says Woodcock did not offer any particularly specific comments about what she expects to come out of the review or how long it might take. She reportedly stressed that FDA is “agnostic” on cannabis and will work to determine the health risks and benefits of marijuana based on an eight-factor assessment.

“If FDA ultimately finds that cannabis has an established medical value,” the post says, “that would directly conflict with its status as a Schedule I drug, which is reserved for substances with no authorized medical use and high abuse potential.”

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