FDA Law Blog

MAY 13, 2024

Gibbs & Ana Loloei & Véronique Li, Senior Medical Device Regulation Expert — FDA has long touted the use of real-world evidence ( RWE ). FDA defines real-world data ( RWD ) as “data relating to patient health status and/or the delivery of health care routinely collected from a variety of sources.” By Jeffrey N.

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The Clinical Problem Solvers

MARCH 14, 2025

Simon is a pediatric addiction medicine psychiatrist at Boston Children’s Hospital; an assistant professor in psychiatry at Harvard Medical School; a recent Commonwealth Fund fellow in health policy at Harvard University; and the medical director of Wayside Youth & Family Support Network.  2022;31(2):211-221. doi:10.1016/j.chc.2022.01.002

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The Clinical Problem Solvers

MAY 9, 2021

Roberts JD For the patient I see tomorrow: Beyond recognizing that race is not a proxy for biology, we can all ask ourselves “What way is structural racism affecting my patient and what can I do about it?” For example, GFR- race correction for Black patients.

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FDA Law Blog

MAY 19, 2025

86, 72703 (December 22, 2021), DEA emphasized in the Gulf Med decision that prescribing [r]ed flags are circumstances surrounding a prescription that cause a pharmacist to take pause, including signs of diversion or the potential for patient harm. As mentioned in Federal Register Vol. Complaint, 82. 81, 86, 251. 81, 86, 251. 81, 89, 251.

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The Clinical Problem Solvers

APRIL 24, 2025

Simon is a pediatric addiction medicine psychiatrist at Boston Children’s Hospital; an assistant professor in psychiatry at Harvard Medical School; a recent Commonwealth Fund fellow in health policy at Harvard University; and the medical director of Wayside Youth & Family Support Network.  2022;31(2):211-221. doi:10.1016/j.chc.2022.01.002

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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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PEMBlog

SEPTEMBER 23, 2024

Andrea De Jesús Martínez Chief PEM Fellow at Baylor College of Medicine | Texas Children’s Hospital Instagram: @bcm_pemfellows Co-author: Benjamin Silva, MD, MPH The Case A 4-year-old male with no significant past medical history presents with headache and vomiting. This patient had a subsequent brain MRI that also revealed papilledema.

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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. According to the Medical Device Databases webpage, the De Novo database is to be updated weekly.

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FDA Law Blog

FEBRUARY 21, 2022

From 1997 to 2003, Dr. Unger served as a medical officer, team leader, and subsequently branch chief in FDA’s Center for Biologics Evaluation and Research (“CBER”). Dr. Unger transitioned to the Office of Drug Evaluation-I in 2009, and became its Director in 2012.

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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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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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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.

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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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FDA Law Blog

FEBRUARY 27, 2024

FDA also approved two NDAs on the same first day for micafungin (MYCAMINE)—NDA 021506 for prophylaxis of Candida infections in patients undergoing hematopoietic stem cell transplantation, and NDA 021754 for the treatment of esophageal candidiasis. In that case, the NDA sponsor applied for two PTEs based on these approvals—one for either U.S.

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The Health Policy Exchange

MARCH 14, 2013

In this month's Georgetown University Health Policy seminar, we discussed the financial and political challenges that AHRQ and its predecessor, the Agency for Health Care Policy and Research (AHCPR) have faced while trying to improve outcomes and effectiveness of medical care since the latter's founding during the first Bush Administration.

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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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PEMBlog

JUNE 2, 2025

Upon entering the room, you find the patients nurse at the bedside already in mid-conversation with the patients parent. In pediatric patients, this condition should be considered when blood pressure exceeds the 95th percentile for age, height, and sex by more than 30 mm Hg, or reaches levels above 180/120 mm Hg in older adolescents.

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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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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

MAY 24, 2023

Patient that are agitated should always be treated with dignity and respect. 2012 Jan;109(3):27-32. Structured team approach to the agitated patient in the emergency department. 2012 Feb;13(1):35-40. Deaths due to physical restraint. Dtsch Arztebl Int. PMC3272587. Coburn VA, Mycyk MB. Emerg Med Australas. PMID: 19527279.

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FDA Law Blog

FEBRUARY 9, 2022

DEA regulations state that a pharmacist has a corresponding responsibility not to fill a prescription unless it is issued for a “legitimate medical purpose by an individual practitioner acting in the usual course of [their] professional practice.” 12, 2012) (quoting Bob’s Pharmacy & Diabetic Supplies; Revocation of Registration, 74 Fed.

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The Clinical Problem Solvers

NOVEMBER 16, 2020

Medicine has never been an apolitical field, and understanding the specific ways the medical field contributed to socio-political definitions of race through practices rooted in medical racism can help us avoid repeating the same harms of the past (e.g. How is racism causing the outcomes that I am seeing in my patient?

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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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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

Guidelines for field triage of injured patients: recommendations of the National Expert Panel on Field Triage, 2011. 2012 Jan 13;61(RR-1):1-20. The most common injuries seen in these younger patients are growth plate fractures and ligamentous injuries. MMWR Recomm Rep. PMID: 22237112. than it is spinal shock.

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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. I’m asking you, have you ever walked in and talked to a black, older black patient and used their first name?

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Physicians News Digest

APRIL 3, 2025

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.

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