FDA Law Blog

OCTOBER 14, 2024

California Stem Cell Treatment Center, Inc., The District Court in this case, which came to the opposite conclusion and is now reversed, was a notable outlier in a string of cases in other circuits upholding FDA’s authority to regulate stem cell clinics on similar grounds as the Ninth Circuit did here. 2014); U.S. By Steven J.

Clinic 59

Clinic Patient-Centered Asthma Patients 59

FDA Law Blog

NOVEMBER 1, 2023

Regulating LDTs: A Long and Winding Road In what might sound to some like protesting too much, the PR invokes FDA’s longstanding assertion that IVDs “manufactured” by laboratories are medical devices and that clinical laboratories that develop tests are acting as manufacturers. FDA’s position is, however, only one side of the story.

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Manufacturing Hospital Healthcare Medical 81

FDA Law Blog

JUNE 23, 2021

Valentine — For the last 13 years, this blogger has been at the center of what has now been dubbed “patient-focused drug development.” For 6 years, I served as a patient liaison within FDA in what was then called the Office of Special Health Issues. By James E. The practice of medicine was viewed as paternalistic.

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Patients Patient-Centered Clinic IT 52

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

GeriPal

APRIL 10, 2025

I asked emergency medicine clinicians what they thought when a patient who is seriously ill and DNR comes to the ED, and some responded, (paraphrasing), what are they doing here? Most emergency providers wanted to do the right thing for seriously ill patients, but they didnt have the knowledge, skills, or experience to do it.

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Patient-Centered IT Hospital Patients 78

GeriPal

APRIL 6, 2023

Today we have a star-studded lineup, including Lexy Torke of Indiana University, who discusses her RCT of a chaplaincy intervention for surrogates of patients in the ICU , published in JPSM and plenary presentation at AAHPM/HPNA. These studies are important. Randomized controlled trials of chaplaincy interventions.

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IT Patient-Centered Families Family 99