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FDA’s Issues Draft Guidance on Accelerated Approval: A Substantial Evidentiary and Procedural Overhaul to this High-Profile Pathway

FDA Law

Sasinowski On December 5, 2024, FDA published a new draft guidance on accelerated approval providing a much needed and substantial update to its guidance on the pathway. FDAs December 5, 2024 draft guidance on accelerated approvals appears intended to cover each of these topics even if not by dividing them precisely along those lines.

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What is going on with MAID in Canada? Bill Gardner, Leonie Herx, & Sonu Gaind

GeriPal

In further contrast to the United States, MAID in Canada is almost entirely administered by a clinician, whereas in the United States patients must self administer. A planned expansion of MAID to include people with mental illness was placed on hold until March 2024. ABIM MOC credit will be offered to subscribers in November, 2024.

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Allowing Patients to Die: Louise Aronson and Bill Andereck

GeriPal

And Bill Andereck is still haunted by the decision he made to have the police break down the door to rescue his patient who attempted suicide in the 1980s, as detailed in this essay in the Cambridge Quarterly of HealthCare Ethics. And he’s also chaired the California Pacific Medical Center’s ethics committee since 1985.

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Guiding an Improved Dementia Experience (GUIDE) Model: A Podcast with Malaz Boustani and Diane Ty

GeriPal

Don’t get me wrong, the evidence points to cost savings, but as Chris Callahan and Kathleen Unroe pointed out in a JAGS editorial in 2020 “in comprehensive dementia care models, savings may accrue to Medicare, but the expenses accrue to a fluid and unstable network of local service providers, patients, and their families.”

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Evidence v. Belief: What a Kennedy Appointment Could Mean to FDA and Public Health

FDA Law

Incentives to motivate better nutritional choices and increase physical fitness would be welcome. Some insights come from an op-ed Kennedy wrote in the Wall Street Journal on September 5, 2024, setting forth some of his plans for a healthier America. Wise government officials will modulate their views as they learn new facts.