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 ). RWE is “the clinical evidence regarding the usage, and potential benefits or risks, of a medical product derived from analysis of RWD.” By Jeffrey N.

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Physician's Weekly

JUNE 24, 2025

Robin Wolaner, 71, a retired publisher in Sausalito, California, has been known to badger friends who delay getting recommended shots, sending them relevant medical studies. Some older people are really eager to be vaccinated. “I’m sort of hectoring,” she acknowledged.

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FDA Law Blog

NOVEMBER 20, 2024

Chemical characterization identifies and quantifies chemicals that may be released from the medical device, while a toxicological risk analysis (TRA) evaluates the risks to the patient associated with the chemicals identified. FDA is extending the comment period on the notice published September 20, 2024 ( 89 FR 77162 ).

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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.  Accessed 2024. Ring the Alarm.

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Mental Health Community Patient-Centered Hospital 52

FDA Law Blog

SEPTEMBER 22, 2024

MDR FDA discussed a few preliminary steps that it says laboratories should take prepare for submitting MDRs as medical device manufacturers. The LDT-specific Product Codes are as follows: SCE : IVD offered as LDT, first marketed before May 6, 2024, and not modified beyond scope described in preamble to LDT Final Rule. By Steven J.

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FDA Law Blog

OCTOBER 24, 2022

These data are routinely collected from a variety of sources, such as electronic health records, providing information on health and healthcare in actual patients, rather than in the controlled environment of a clinical trial. This value is potentially even greater for rare diseases, where there are limited sources of data.

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The Motivated MD

OCTOBER 10, 2024

Further, no part of this series, post, or any post on this website may be reproduced, stored in a retrieval system, or transmitted in any form or by any means, electronic, mechanical, photocopying, recording, scanning, or otherwise, except as permitted under the 1976 United States Copyright Act, without the prior written permission of the author.

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Finance Individual Management IT 52

Annals of Family Medicine

NOVEMBER 20, 2024

To assist with smoking cessation, there are several FDA-approved medications, like nicotine replacement, varenicline, or bupropion. Setting & Population Studied De-identified electronic health record data of patient demographics and treatment from health systems participating in the Epic Cosmos database were accessed.

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Medical Xpress

JUNE 16, 2025

A 2024 study published in the journal Nature Medicine found that military veterans with brain injuries saw major mental and physical improvements after just one ibogaine session. The information you enter will appear in your e-mail message and is not retained by Medical Xpress in any form. In Brazil, the therapy has helped thousands.

Mental Health 52

Mental Health IT Medical Specialization 52

Medical Xpress

JUNE 16, 2025

The information you enter will appear in your e-mail message and is not retained by Medical Xpress in any form. Learn more Your name Note Your email address is used only to let the recipient know who sent the email. Neither your address nor the recipients address will be used for any other purpose. What are the consequences?

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Provider Complication Medical Diabetes 109

The Motivated MD

SEPTEMBER 19, 2024

For the better half of 2024, I have been periodically writing posts that are individual articles that double as potential chapters to a future book. A study by Johns Hopkins in 2016 found that medical errors may potentially be the third leading cause of death nationwide. So yes, humans make mistakes. Not an easy thing to do.

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Finance Individual Education Healthcare Professional 52

GeriPal

FEBRUARY 29, 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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IT Patient-Centered Illness Education 126

GeriPal

APRIL 4, 2024

Bernie Lo discloses being an Honorarium Recipient and consultant for Takeda starting on 01/23/2024. ABIM MOC credit will be offered to subscribers in November, 2024. And the classic case that we often hear of is the poor old person who got a whole lot of medical treatment they wouldn’t have wanted an ICU flog.

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Families Family Patient-Centered IT 112

PEMBlog

MARCH 27, 2024

She aims to become a physician-scientist in pediatrics and medical genetics, engaging in bench-to-bedside research that utilizes multi-omics-based approaches to provide a molecular diagnosis and support personalized care for individuals with suspected rare genetic diseases and their families. Brad’s not a pediatric medical geneticist.

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Consulting Individual Families Family 59

GeriPal

APRIL 6, 2023

A friend of GeriPal, and prior guest, Guy Micco commented today that we need an RCT for chaplaincy is like the idea that the humanities need to justify their value in medical training: “It’s like being told to measure the taste of orange juice with a ruler.” Really important person, who later in his life got very interested in healthcare.

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IT Patient-Centered Families Family 99

GeriPal

SEPTEMBER 5, 2024

And he’s also chaired the California Pacific Medical Center’s ethics committee since 1985. Louise 05:02 Yes, well, I don’t know about 2024, but in 2023, yes, it could happen. But one of the things I worry about, when we really know medically where this case is going and we find, how many times has this happened?

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Patients IT Patient-Centered Hospital 98

GeriPal

APRIL 18, 2024

And I wonder, now, was this 2024 version sort of a redo? Then, it was like, well, it does as well as, and now, better than humans passing the medical boards, passing the law boards, doing great on the SAT, all that stuff. That’s a risk with electronic health records in general. And the first one was with Zeke Emanuel.

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IT Electronics Patients Healthcare 139

FDA Law Blog

MAY 21, 2024

The 2016 reviews concluded that marijuana continued to meet schedule I criteria for having a high potential for abuse, no currently accepted medical use in treatment in the U.S., and lacked accepted safety for use under medical supervision. 44,597 (May 21, 2024). Currently Accepted Medical Use in Treatment in the U.S.

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Physicals Medical Clinic Emergency Room 69

GeriPal

SEPTEMBER 19, 2024

And then we started pushing a lot more surveys electronically to patients, which, of course, has its challenges, because not everyone’s as tech savvy as, you know, our highly educated patients who have access to technology. This 2024 is the year of AI. ABIM MOC credit will be offered to subscribers in November, 2024.

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Patient-Centered IT Patients Hospital 119

Medical Xpress

JUNE 7, 2025

The information you enter will appear in your e-mail message and is not retained by Medical Xpress in any form. Learn more Your name Note Your email address is used only to let the recipient know who sent the email. Neither your address nor the recipients address will be used for any other purpose. What are the consequences?

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Vaccination Insurance Medical Diabetes 64

GeriPal

MARCH 27, 2025

And interesting enough, this is a really fascinating study that just got published in JAMA I M in December of 2024. So we have to collect what information we have available from Health Information exchange and electronic health records. Sydney 22:01 Well, it’s what’s in the electronic health record. Eric 22:03 Okay.

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Primary Care IT Clinic Patient-Centered 79

Medical Xpress

JUNE 8, 2025

While more than 45,000 active volunteer surf lifesavers and 1,350 professional lifeguards provided services at beaches across Australia in 2024, an estimated 740,000 surfers were on the coastline, across patrolled and unpatrolled locations. Sometimes, bystanders become victims themselves. What are the consequences?

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Provider Community Medical Diabetes 53

Medical Xpress

JUNE 23, 2025

Other factors including humidity, wind and peoples ages and medical conditions play a role in heat illness as well, Wood says. When he worked on a medical mission in Haiti, he got used to seeing people wrap their heads in water-soaked towels and throw ice down their groin. 40°C (101–104°F).

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Physician's Weekly

JUNE 17, 2025

But that’s when his family began fighting another adversary: their health insurer, which decided the treatment was “not medically necessary,” according to insurance paperwork. In some cases, it is used to intentionally generate profits for health insurers, according to a 2024 U.S. Senate report.

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