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FDA’s Draft Guidance on Externally Controlled Trials Answers Some Questions, Leaves Others Unanswered

FDA Law Blog

Notably, the Draft Guidance states that it is not intended to address other types of external controls, such as using summary-level estimates instead of patient-level data, nor does it discuss the use of external control data to supplement a control arm in a traditional randomized controlled clinical trial.

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Episode 240: Anti-Racism in Medicine Series – Episode 17 – ‘Just’ Births: Reproductive Justice & Black/Indigenous Maternal Health Equity

The Clinical Problem Solvers

She urges us to recognize that maternal mortality changes the life trajectories of individuals and communities. Excerpt from Dismantling Racism: A Workbook for Social Change Groups, by Kenneth Jones and Tema Okun, ChangeWork, 2001. The Clinical Problem Solvers Podcast – Antiracism in Medicine Series. May 31, 2022.

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The Future of Geriatrics: A Podcast with Jerry Gurwitz, Ryan Chippendale, and Mike Harper

GeriPal

So a couple weeks after it was published, I took a trip to a medical school in the western part of the country and I was visiting to think about their geriatrics research program, and they had a geriatrics evaluation clinic. And I met with the clinical pharmacist who worked in that clinic and she told me, “You know what?

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A Podcast on Inhalant Misuse: From Glue to Galaxy Gas

PEMBlog

Well dive into the clinical presentations, including acute and chronic symptoms, the dangers of sudden sniffing death, and the specific risks associated with nitrites, hydrocarbons, and nitrous oxide. Inhalant misuse reported to Americas Poison Centers, 2001-2021. Ganetsky M (ed). Updated February 26, 2024. Accessed January 13, 2025.

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Is Hospice Losing Its Way: A Podcast with Ira Byock and Joseph Shega

GeriPal

I think some individuals thought there was cherry-picking of stories that made it seem like hospice is this bad thing, that it’s taking advantage of vulnerable individuals and it didn’t talk enough about the good things that hospice does. On the other side, there’s another group that thinks, you know what?

IT 115