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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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Opill’s FDA Approval: Implications for Pharmaceutical Regulation and Access to Care

Bill of Health

By James René Jolin and Susannah Baruch On July 13, 2023, the United States Food and Drug Administration (FDA) approved Opill (norgestrel) as the first daily oral contraceptive available for non-prescription use in the U.S. James René Jolin (JRJ): This recent move by the FDA is one without precedent. It was a long time coming.

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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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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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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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Book Review: ‘Drugs and the FDA: Safety, Efficacy, and the Public’s Trust’ by Mikkael A. Sekeres

Bill of Health

In Drugs and the FDA: Safety, Efficacy, and the Public’s Trust , oncologist Mikkael A. Sekeres centers his narrative on the controversial 2011 Avastin hearings , in which the FDA reconsidered and ultimately withdrew the breast cancer indication for Genentech’s Avastin drug. By Matthew Chun.

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