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. These legislative changes helped.

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FDA Law Blog

JUNE 23, 2021

In 2012 we at the Agency, under Dr. Janet Woodcock’s leadership, identified the need for more systematic patient engagement — a way to improve representativeness and be more proactive rather than reactive to interacting with patient communities. However, the scope of patient input goes beyond setting the clinical context.

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PEMBlog

MAY 11, 2023

And what about the J-Tip, a device that uses pressurized gas to send medication into the subcutaneous portion of the skin – deeper than topical anesthetics? 2012 Jul;28(7):687-90. This helps to open up the spaces between the vertebrae and makes it easier for the needle to enter. What about topical anesthetics? Pediatr Emerg Care.

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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

JUNE 9, 2025

These events marked a turning point in expanding representation in clinical studies and opening the door to more personalized medical care. These events marked a turning point in expanding representation in clinical studies and opening the door to more personalized medical care.

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Annals of Family Medicine

NOVEMBER 20, 2024

Conclusions This study shows wide variation among HPV vaccine uptake among children and adolescents in a multi-state network of community-based clinics, with higher uptake in Latino patients, especially foreign-born Latinos. It remains uncertain how ethnicity and country of birth relate to HPV vaccination among younger Latinos.

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FDA Law Blog

JUNE 7, 2021

However, the FDA guidance goes on to say in some cases, additional context is needed by specifically inserting a sentence in the indications statement that: no clinical benefit has been established. be “reasonably likely to predict” ultimate clinical benefit). This has been a decision we’ve been closely following. What do we mean?

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GeriPal

MARCH 2, 2023

By 2015 that number increased to 4% of US adults. There are a lot of reasons that may explain the massive increase in use of these drugs. One thing is clear, it is not because people are using it for FDA approved indications. The FDA-approved indications for gabapentin are only for treating patients with partial seizures or postherpetic neuralgia.

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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. Hypertensive emergency is a clinical diagnosis characterized by a sudden and severe elevation in blood pressure accompanied by signs of acute end-organ dysfunction. Look for the underlying cause renal disease leads the list in kids.

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Permanente Medicine

APRIL 29, 2025

From 2012 to 2016, death rates from colorectal cancer among Black people were nearly 40% higher than in whites and double that seen in Asians and Pacific Islanders, according to the American Cancer Society. Levin, MD , a Kaiser Permanente Division of Research scientist and gastroenterologist with The Permanente Medical Group.

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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? Cartwright’s study influenced the equations that medical professionals still use to calculate the impact of various diseases on lung function. How is race a social construct? racial essentialism).

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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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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. But before we jump into that topic, John, do you have the song request for Alex? John: I do.

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GeriPal

FEBRUARY 2, 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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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. 2012 Jan 13;61(RR-1):1-20. Cervical Spine Injuries are fortunately rare in children. Here is the aforementioned PECARN paper: Leonard, J.

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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

Pediatrics November 2012; 130 (5): e1416–e1423. 2012-2481 Haasz, M., I’m Dr. Carney and I am a pediatric resident at Cincinnati Children’s Hospital Medical Center. Today, we are going to discuss firearm safety and ways to screen for it in both the ED and clinic settings. Melzer-Lange, Joseph O’Neil, Wendy J. Beidas, R.

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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

What a Wonderful World could be sung in irony at this moment. I hope we all take it literally, with the hope this podcast ends with. Alex Smith ** This podcast is not CME eligible. To learn more about CME for other GeriPal episodes, click here. Transcript Eric 00:00 Welcome to the GeriPal Podcast. It is a terrific book. Alex 02:07 Yeah, I love it.

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