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FDA’s Draft Guidance on Externally Controlled Trials Answers Some Questions, Leaves Others Unanswered

FDA Law Blog

This Draft Guidance focuses on the use of patient-level data from other clinical trials or from RWD sources. The goal is to select similar patients in the treatment and external control groups. The Draft Guidance also states that sponsors must include in their marketing applications relevant patient-level data for both arms.

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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. She happened to focus on some specific for-profit hospice providers.

IT 115
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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

We all must recognize the codification of racism within our institutions and work to unlearn these hierarchies in order to better care for Black and Indigenous patients. She urges us to recognize that maternal mortality changes the life trajectories of individuals and communities. link] Kenneth J, Okun T. White Supremacy Culture.

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A Podcast on Inhalant Misuse: From Glue to Galaxy Gas

PEMBlog

Learn how to recognize and manage cases in the emergency department, ask the right questions to uncover inhalant use, and provide critical resources for prevention and support. Formulate effective strategies for identifying, managing, and preventing inhalant misuse in pediatric patients. References Perry H, Burns MM. Ganetsky M (ed).

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

GeriPal

” You can look back to an ACP paper in 2001 saying that the only way geriatrics survive is that we have to do this, and this doesn’t feel like a new conversation. And he asked me questions like, “Why is this patient in bed? Oh, woe is us. Everything is so bad.” Go ahead, Mike. Why do they have a Foley catheter?”

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Marijuana: Top Ten Reasons for Descheduling, Rescheduling or Not

FDA Law Blog

The three letters together provide the range of actions DEA may take: no rescheduling from schedule I (former drug officials), rescheduling to schedule III (Democratic state attorneys general), or descheduling altogether (Democratic senators). Letter 1 is signed by former DEA administrators and Directors of National Drug Policy.

Medical 59
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Trump Whacks Agency That Makes the Nation’s Health Care Safer

Physicians News Digest

The episodes turned both women into advocates for patients and spurred research that made American health care safer. Haskell, of Columbia, South Carolina, has done research and helped write AHRQ-published surveys and guidebooks on patient engagement for hospitals. It also has published tools and guidelines to enhance patient safety.