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FDA’s Draft Guidance on Externally Controlled Trials Answers Some Questions, Leaves Others Unanswered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This Draft Guidance focuses on the use of patient-level data from other clinical trials or from RWD sources.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 The Draft Guidance also states that sponsors must include in their marketing applications relevant patient-level data for both arms.

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

GeriPal

Alex: Today we’re delighted to welcome Jerry Gurwitz, who is a geriatrician and professor of medicine at the UMass Chan Medical School. I talked about lack of prestige and respect, and I talked about how healthcare system leaders and medical school deans don’t always seem to value the field of geriatrics.

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A Podcast on Inhalant Misuse: From Glue to Galaxy Gas

PEMBlog

Formulate effective strategies for identifying, managing, and preventing inhalant misuse in pediatric patients. Inhalant misuse reported to Americas Poison Centers, 2001-2021. Its evolved from its medical and industrial applications to a recreational substance with a significant cultural footprint. Ganetsky M (ed).

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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.