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.

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Patients Patient-Centered Clinic IT 52

FDA Law Blog

JANUARY 12, 2025

Since that time, it was formalized in FDA regulations (21 CFR 314 Subpart H) in 1992, codified in the Food, Drug, & Cosmetic Act by FDAMA (21 USC 356(c)) in 1997, revised by FDASIA in 2012, and described in guidance, most importantly, in the 2014 Expedited Programs for Serious Conditions Drugs and Biologics (2014 Guidance).

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FDA Law Blog

FEBRUARY 29, 2024

As FDA explains on its website (which includes lists— here and here —of the more than 300 Accelerated Approvals (and withdrawals)): The FDA instituted its Accelerated Approval Program to allow for earlier approval of drugs that treat serious conditions, and fill an unmet medical need based on a surrogate endpoint. That did not happen.

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FDA Law Blog

AUGUST 18, 2024

By Véronique Li, Senior Medical Device Regulation Expert & Jeffrey N. In 2012, the FDCA was modified to allow the submission of a De Novo request without the need for a prior 510(k), and set a target review time by FDA of 120 days. Each of these De Novos can represent a clinical advance.

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PEMBlog

MAY 11, 2023

Some general recommendations to reduce pain during LP include: Comfortable Positioning: The patient should be instructed to lie on their side with their knees drawn up to their chest and their chin tucked in, or sit upright with their head and upper back forward (often on a bedside table with a pillow). for the lidocaine group and 4.8 (0.5)

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Patient-Centered Provider IT Patients 52

Pamela Wible MD

JUNE 20, 2025

(Published 3/18/19, updated 6/20/25) What Is Physician “Burnout”—and Why It Matters Physician “burnout” is a state of emotional, physical, and mental exhaustion caused by prolonged stress in the medical workplace. and it has been linked to rising rates of physician depression , doctor suicide , and medical errors.

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Annals of Family Medicine

NOVEMBER 20, 2024

Some research has found lower HPV vaccine uptake in Latino patients and others have demonstrated higher uptake by Latino subgroups. Results Among both male and female patients, all Latino/a groups had higher odds of vaccine initiation and of ? 2 doses compared to non-Hispanic white adolescents.

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PEMBlog

JUNE 2, 2025

Clinical Case You are a senior resident working in the busy emergency department on an overnight shift. Upon entering the room, you find the patients nurse at the bedside already in mid-conversation with the patients parent. Use IV labetalol or nicardipine continuous drips to lower blood pressure.

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Permanente Medicine

APRIL 29, 2025

Early screening helps erase racial health disparities The study showed a significant reduction of colorectal cancer deaths among Black patients, which decreased from 52 per 100,000 in 2009 to 23.5 Deaths per 100,000 for Hispanic, white, and Asian patients decreased to 20 during the same time period.

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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. It’s not a controlled substance medication. Tasce: Yes. Taylor Swift.

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The Clinical Problem Solvers

NOVEMBER 16, 2020

37:50​ Race vs. ancestry vs genetics–implications for research and clinical practice 52:02 ​What can we start doing tomorrow? How is racism causing the outcomes that I am seeing in my patient? Ignoring race and racism does not negate the profound impact that race and racism have on our BIPOC patients’ health.

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FDA Law Blog

APRIL 8, 2024

The White Paper notes that of the 123 drugs in shortage in January 2024, a quarter were first reported in shortage prior to 2020, with the oldest dating back to 2012, and shortages were experienced across therapeutic areas; analgesics/anesthetics (17%), anti-infective (12%), and cardiovascular (13%) products comprised 42% of shortages.

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PEMBlog

JUNE 5, 2024

It was inspired by a hot-off-the-presses publication from the Pediatric Emergency Care Applied Research Network (PECARN) focused on clinical decision rules for cervical spine imaging in children. Guidelines for field triage of injured patients: recommendations of the National Expert Panel on Field Triage, 2011. Harding, M.,

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GeriPal

MARCH 7, 2024

An end-of-life doula is a non-medical support person that provides a longitudinal relationship with aspects of medical, I mean, aspects of companionship, presence, holding space, some logistics, some practical help, decision making perhaps. There’s an organization that I took my training from, which began, I want to say, in 2012.

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GeriPal

FEBRUARY 2, 2024

First, in our editorial, we expressed concern about the length of stay metric not being patient centric, though important for health systems focused on cost savings. And, of course, this is what families of patients undergoing palliative care go through. This is 24,000 encounters, over 15,000 patients, 11 hospitals, eight states.

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GeriPal

MARCH 20, 2025

Summary Transcript CME Summary Eric and Alex have featured discussions about complex bioethical concepts around caring for people at the end of life, including voluntarily stopping eating and drinking ( VSED ), and multiple episodes about the ethical issues surrounding medical aid in dying ( MAID ). Alex 00:14 We have a very full house today.

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PEMBlog

APRIL 26, 2023

Kit Carney and Dr. Kristen Humphrey discuss gun violence, its impact on our patients and their families, as well as practical tips on advocating for safe storage of firearms, and how we can support victims of violence. Pediatrics November 2012; 130 (5): e1416–e1423. 2012-2481 Haasz, M., Melzer-Lange, Joseph O’Neil, Wendy J.

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GeriPal

AUGUST 1, 2024

Accreditation In support of improving patient care, UCSF Office of CME is jointly accredited by the Accreditation Council for Continuing Medical Education (ACCME), the Accreditation Council for Pharmacy Education (ACPE), and the American Nurses Credentialing Center (ANCC), to provide continuing education for the healthcare team.

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Common Sense Family Doctor

MARCH 23, 2025

Please join me and hundreds of medical organizations in standing with AHRQ and preserving its vital contributions to the health of all Americans. ** For the past 30 years, a little-known U.S. Now the Department of Government Efficiency is trying again, threatening 90% staff reductions that would decimate the agency.

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GeriPal

APRIL 17, 2025

Summary Transcript CME Summary I read Farah Stockmans article in the NYT on why attacks on DEI will cost us all , and thought, Yes, and everyone includes harm to our healthcare workforce, our patients, and their families. Alex 20:58 Farah, appreciate the medicine metaphor for our clinical audience. Well played. It is just impossible.

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