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The FDA Backdoor to MDMA Rescheduling

Bill of Health

Food and Drug Administration (FDA) for post-traumatic stress disorder (PTSD) means the drug may be rescheduled, which will lead to substantially decreased regulations attached to it. However, in 2016, DEA added some clarity to the “accepted medical use” qualification, saying that FDA approval was one way to achieve this threshold.

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FDA approves sleep apnea tech from EnsoData, Samsung

Healthcare It News

EnsoData announced Tuesday that it has received FDA 510(k) clearance for an AI algorithm called EnsoSleep to support the diagnosis of sleep disorders using any FDA-cleared pulse oximeter, which measures the saturation of oxygen carried in red blood cells. in the third quarter. in the third quarter.

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Pig Hearts for Humans and the FDA

Bill of Health

Food and Drug Administration (FDA) has not approved any genetically modified or pure animal organs for xenotransplantation in humans. For the surgery to go forward in Bennett’s case, the team had to submit a request to the FDA seeking to use the pig heart in the emergency procedure (so-called “compassionate use” ). Categorization.

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Tobacco Issues Awaiting Robert Califf at the FDA

Bill of Health

Food and Drug Administration (FDA), bringing a drawn out and contentious process to a close. Califf will be the second-ever FDA Commissioner to serve non-consecutive terms, and the first to have been confirmed by the Senate on two separate occasions. Banning Menthol Cigarettes. Reviewing E-cigarettes.

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FDA Solicits Feedback on the Use of AI and Machine Learning in Drug Development

Bill of Health

Food and Drug Administration (FDA), in fulfilling its task of ensuring that drugs are safe and effective, has recently turned its attention to the growing use of artificial intelligence (AI) and machine learning (ML) in drug development. By Matthew Chun The U.S. manufacturing process design), implement advanced process controls (e.g.,

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Federal judge invalidates FDA approval of abortion pill

Healthcare Dive

approval, and could carry consequences for the FDA’s authority over prescription medicines. The decision imperils access to the drug more than two decades after its U.S.

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FDA staff hold ‘major concerns’ with Brainstorm ALS therapy, documents show

Healthcare Dive

Agency scientists flagged numerous issues with Brainstorm’s stem cell treatment ahead of a high-profile Wednesday meeting of expert FDA advisers.

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