Drugs

FDA Says More CBD Info Needed

FDA officials told an 11/30 meeting of the National Industrial Hemp Council that the agency still believes it needs additional CBD (cannabidiol) research and safety data before it can be considered for uses beyond prescription drugs such as a food additive or dietary supplement. CDER deputy director for regulatory policy Grail Sipes said, “We continue to underscore the need for evidence to support the science, safety profile, and quality of CBD and cannabis-derived products.”

Meanwhile, she said, it is unlawful for CBD to be used as an ingredient in human or animal food, as a dietary supplement, and to be sold in interstate commerce.

“Clear answers to many important questions are still lacking, such as what adverse reactions may be associated with CBD from hemp-derived products and what risks are associated with the long-term use of these products,” Sipes said.

Some industry representatives noted two bills are pending in Congress that would force the agency to regulate food and dietary supplements that contain CBD. They suggested the agency may be waiting for legislation to be approved so that Congress will be responsible for forcing FDA action.

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