Drugs

OMB Reviewing FDA Cannabis Document: Report

The White House Office of Management and Budget (OMB) reportedly is reviewing an FDA document, “Cannabis and Cannabis-Derived Compounds: Quality Considerations for Clinical Research,” that industry executives hope represents progress in the agency’s examination of whether and how to regulate the market for CBD (cannabidiol) in dietary supplements and other products.

Natural Products Insider reports online that OMB received the document 5/28, about one year after FDA held a public meeting about products containing cannabis.

Agency spokesman Nathan Arnold told the newsletter FDA could not comment on the guidance until it is published. OMB did not respond to the newsletter’s request for comment on the substance of the guidance or its timing for reviewing it and sending it back to FDA.

Industry executives are quoted in the article expressing disappointment at how long it has taken FDA to develop a national regulatory regime for products containing hemp-derived CBD.

Arnold e-mailed a statement to the newsletter saying that FDA is “working toward a goal of providing additional guidance, and has made substantial progress. There are many questions to explore regarding the science, safety, effectiveness, and quality of products containing CBD, and we need to do our due diligence.”

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