FDA Policy/General

Comments Sought on Scheduling for 8 Drugs

Federal Register notice: FDA is seeking comments by 8/23 on the abuse potential, actual abuse, medical usefulness, trafficking, and impact of scheduling changes on medical use availability for eight drug substances. The comments will be considered in preparing a response to the World Health Organization about the abuse liability and diversion of the drugs so it can consider whether to recommend certain international restrictions that can be placed on them. The drugs are:

Hexahydrocannabinol, a semi-synthetic cannabinoid.
N-Pyrrolidino protonitazene, a synthetic opioid of the nitazene family
N-Pyrrolidino metonitazene, a synthetic opioid of the nitazene family
N-Piperidynyl etonitazene, a synthetic opioid of the nitazene family
N-Desethyl-isotonitazene, a synthetic opioid of the nitazene family
3-Hydroxy-phencyclidine, a dissociative hallucinogen of the arylcyclohexylamine class
N-Ethylheptedrone, a stimulant from the substituted cathinone drug class
Carisoprodol, a sedative-hypnotic

To view the notice, click 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