FDA Law Blog

JANUARY 12, 2025

Sasinowski On December 5, 2024, FDA published a new draft guidance on accelerated approval providing a much needed and substantial update to its guidance on the pathway. However, the 2014 Guidance cannot be ignored entirely. By Charles G. Raver & James E. Valentine & Ellis Unger & Frank J.

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Clinic Relationship Provider IT 64

FDA Law Blog

NOVEMBER 1, 2023

Indeed, recent jurisdictional developments suggest that a wide of array of stakeholders could have standing to challenge the Agency’s attempt to restrict access to commonly used LDTs, including individual laboratories, hospitals, physicians and healthcare providers who routinely use these tests, and patients who depend on them.

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Manufacturing Hospital Healthcare Medical 81

FDA Law Blog

FEBRUARY 29, 2024

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. According to documents in the PTO’s Patent Center, Lilly has not yet filed a response.

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Clinic IT Provider Patient-Centered 59

The Clinical Problem Solvers

MARCH 4, 2024

During this episode, we hear from Zahra Khan, an educator and editor who has written extensively on abolition in medicine, and Dr. Sayantani DasGupta, a physician-educator, prolific children’s book author and faculty at the Center for the Study of Ethnicity and Race and the Institute for Comparative Literature and Society at Columbia University.

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Community Education Patient-Centered Relationship 52

GeriPal

MARCH 2, 2023

The FDA-approved indications for gabapentin are only for treating patients with partial seizures or postherpetic neuralgia. valproic acid and gabapentin), in nursing homes, particularly patients with Alzheimer’s disease and related dementias. There are a lot of reasons that may explain the massive increase in use of these drugs.

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Patient-Centered IT Healthcare Medical 96

PEMBlog

JUNE 5, 2024

Sasser SM, Hunt RC, Faul M, Sugerman D, Pearson WS, Dulski T, Wald MM, Jurkovich GJ, Newgard CD, Lerner EB; Centers for Disease Control and Prevention (CDC). Guidelines for field triage of injured patients: recommendations of the National Expert Panel on Field Triage, 2011. 2014 May;133(5):e1179-88. MMWR Recomm Rep. Pediatrics.

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Patient-Centered Patients IT Hospital 52

GeriPal

MARCH 6, 2025

link] PEACH Good Wishes Program A program that provides meaningful gifts for unhoused individuals who are terminally ill. They can’t believe it, but we come back again and again and again gently to provide that support. And so the attitude has unfortunately become like, we just don’t provide care to folks.

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Healthcare IT Community Illness 102