FDA Policy/General

Senate Passes Marijuana/CBD Research Bill

The Senate 3/24 passed the “Cannabidiol and Marijuana Research Expansion Act” that is intended to ensure that research on cannabidiol (CBD) and other potentially beneficial marijuana-derived substances is based on sound science while simultaneously reducing the regulatory barriers associated with conducting related research. Introduced by Sens. Chuck Grassley (R-IA) and Dianne Feinstein (D-CA), the bipartisan bill “will empower the FDA to analyze CBD and medical marijuana products in a safe and responsible way so that the American public can decide whether to utilize them in the future based on sound scientific data,” the lawmakers said.

“Current rules and regulations make it hard for researchers to study how marijuana and marijuana-derived medications can best be used to treat various conditions,” said Feinstein. “This important legislation will cut the red-tape around the research process, helping get FDA-approved, marijuana-derived medications safely to patients.”

Currently, both marijuana and CBD containing more than 0.3 percent delta-9 tetrahydrocannabinol (commonly known as THC) are classified as Schedule I drugs. “As a result, medical research is subject to stringent regulations that can impede new developments,” they say. “CBD is largely unregulated, but thousands of parents nationwide have used CBD oil to help their children who suffer from intractable epilepsy. Few marijuana-derived products have been FDA-approved, and there is little available information about their interactions with other medications, appropriate doses or delivery mechanisms.”

Full text of the bill can be found by clicking Here.

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