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Episode 392: Antiracism in Medicine – Episode 27 – Racial and Gender Health Disparities in Youth Suicide: Part 2

The Clinical Problem Solvers

Dr. Benton mentors clinical and research physicians, fellows, and postdoctoral trainees. Clinically, he cares for youth and families through the Department of Psychiatry & Behavioral Sciences and the new Division of Addiction Medicine at Boston Children’s Hospital. Child and Adolescent Psychiatric Clinics of North America.

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FDA’s Issues Draft Guidance on Accelerated Approval: A Substantial Evidentiary and Procedural Overhaul to this High-Profile Pathway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

Sasinowski On December 5, 2024, FDA published a new draft guidance on accelerated approval providing a much needed and substantial update to its guidance on the pathway. an intermediate clinical endpoint) and that is reasonably likely to predict an effect on irreversible morbidity or mortality or other clinical benefit.

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Long Time Passing: Where Have All the De Novo Decision Summaries Gone?

FDA Law Blog

The De Novo process provides a regulatory pathway to classify novel devices for which general controls alone or general and special controls provide reasonable assurance of safety and effectiveness for the intended use. Each of these De Novos can represent a clinical advance.

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Surely You Must be Kidding, PTO?!? “No, and Don’t Call Me Shirley!” – The Seemingly Slapstick (But Yet Unfunny) World of Recent Patent Term Extension Decisions (PART 2)

FDA Law Blog

A surrogate endpoint is a marker, such as a laboratory measurement, radiographic image, physical sign or other measure that is thought to predict clinical benefit but is not itself a measure of clinical benefit. Drug companies are still required to conduct studies to confirm the anticipated clinical benefit.

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Under Pressure: Hypertensive Emergencies in the Pediatric Emergency Department

PEMBlog

Clinical Case You are a senior resident working in the busy emergency department on an overnight shift. Before your blood pressure rises as well, know that this PEMBlog article is here to provide an overview of the recognition and management of hypertensive emergencies. All kids with hypertensive emergency need ICU-level care.

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Gabapentinoids – Gabapentin and Pregabalin: Tasce Bongiovanni, Donovan Maust and Nisha Iyer

GeriPal

Eric: Any other interesting tidbits or facts that we should know as providers about gabapentin or Lyrica dosing or pharmacology? There was this big thing called the CMS National Partnership to Improve Dementia Care, started in 2012. I understand that it can be a hard place clinically.

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A podcast episode about laryngomalacia

PEMBlog

2012 Oct;147(4):619-26. But it might underestimate it because lots of mild cases don’t actually present clinically, and they’re not diagnosed endoscopically. The physical exam of a Child with possible laryngeal malaysia focuses on the airway and breathing naturally. Available from: [link] Hartl TT, Chadha NK.