Drugs

Bill Would Ease Marijuana Research Restrictions

Bipartisan legislation in both the House and Senate would amend the Controlled Substances Act to ease federal obstacles for medical researchers to conduct clinical studies on the medical benefits of marijuana, according to four Arent Fox attorneys in an online post. They say the Marijuana Effective Drug Studies (MEDS) Act of 2016 does not take a position on legalization of marijuana, but would create a faster process for obtaining Drug Enforcement Administration (DEA) approval to conduct research on its uses, addressing major barriers faced by researchers who want to study the drug’s potential medical uses.

The legislation also would instruct the DEA to establish manufacturer licenses for the commercial production of FDA-approved medical marijuana products.

The attorneys say that the bill responds to increasing concerns that current federal policies governing medical research on the efficacy and safety of marijuana are so cumbersome that they create obstacles for the scientific community to conduct clinical research that is critical to informing medical practice.

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