FDA Law

OCTOBER 18, 2022

By Véronique Li, Senior Medical Device Regulation Expert & Philip Won — Last week, our blog post advised planning a transition strategy in advance of the news of the termination of the Covid-19 public health emergency. On October 17, 2022, FDA published the list of CDRH proposed guidances for FY 2023 (see here ).

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Medical Electronics Complication Clinic 52

FDA Law

DECEMBER 13, 2023

Sasinowski — On December 12, 2023, FDA announced the creation of a new advisory committee specifically for treatments for genetic metabolic diseases, the Genetic Metabolic Diseases Advisory Committee, or “GeMDAC.” GeMDAC’s mandate is to advise the Agency on these complicated issues in this challenging area of medical product development.

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FDA Law

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.

Clinic 59

Clinic IT Provider Patient-Centered 59

PEMBlog

APRIL 20, 2023

Rather, it can change the bleeding phenotype from severe hemophilia to mild hemophilia – thus potentially reducing the risk of complications. Patients on emicizumab will have it listed on their medication list. Epub 2023 Jan 16. Emicizumab, though, does not fully normalize hemostasis. How to know if a patient is on it?

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Individual Patient-Centered Patients IT 52

Annals of Family Medicine

NOVEMBER 20, 2024

The Centers for Disease Control and Prevention recommends discussing family planning and preconception counseling at the domestic medical exam (DME), yet there is little guidance on specific counseling needs in this population. Population Studied Inclusion criteria were ages 16-45 with a DME performed between 2018 and 2023.

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PEMBlog

AUGUST 20, 2024

2023; 187:109792. So, eCPR, extracorporeal cardiopulmonary resuscitation, is an advanced medical procedure used in cases of cardiac arrest where traditional CPR has failed. Rationale and methods of the advanced R2Eperfusion STrategies for refractory cardiac ARREST (ARREST) trial. Am Heart J. 2020;229:29–39. Bartos JA, Yannopoulos D.

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Patient-Centered Hospital Patients IT 52

FDA Law

FEBRUARY 28, 2023

Lenz, Principal Medical Device Regulation Expert — Since 2005, 510(k) submissions have been formatted according to FDA guidance Format for Traditional and Abbreviated 510(k)s. As anyone who has ever worked on a lengthy and/or complicated AI response knows, these responses do not always fit neatly in a text box. By Adrienne R.

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Provider Electronics IT Complication 52

Annals of Family Medicine

NOVEMBER 20, 2024

Population Studied: We started with 29,620 deliveries at IHC between May 1, 2009, and May 31, 2023. We excluded deliveries complicated by known RFs for PTB (n=12,646). Setting: IHC, Iowa City, IA.

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Doctor On Demand

APRIL 28, 2025

Here’s a closer look at the red-flag symptoms that signal it’s time to visit urgent care for a sore throat: Severe sore throat or trouble swallowing A severe sore throat or trouble swallowing suggests you might have a more complex underlying cause needing urgent medical attention. These symptoms require immediate medical attention.

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ER Telehealth Primary Care Doctor Appointment 52

Annals of Family Medicine

NOVEMBER 20, 2024

Study Design: Secondary data analysis of a retrospective cohort from 2017-2023. Setting or Dataset: 4 primary care clinics (PCCs) across Maine, New Hampshire, and Vermont. Population: 569 adults with chronic pain treated with opioids for 5 or more prescriptions or 1000+ morphine mg equivalents (MME) per year.

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Patients Patient-Centered Primary Care Electronics 130

Medical Xpress

JUNE 16, 2025

But what we observed was much more complicated." The information you enter will appear in your e-mail message and is not retained by Medical Xpress in any form. The traditional model is simple: SCN neurons were believed to act like runners in a relay race, passing the light signal along in a linear chain. What are the consequences?

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Provider Complication Medical Diabetes 109

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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Mental Health IT Medical Specialization 52

Physician's Weekly

JUNE 19, 2025

About 3 in 10 adults reported not taking their medicines as prescribed at some point between July 2022 and July 2023 because of the cost, according to a KFF survey. When Bob changed jobs, the price tag for his daughter’s medication went through the roof. They started trying out different medications and dosages.

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Insurance IT Board-Certified Medical 52

Physician's Weekly

JUNE 23, 2025

MONDAY, June 23, 2025 (HealthDay News) — The National Institutes of Health (NIH) will fund studies of the long-term health effects of a 2023 Ohio train derailment that released more than 1 million pounds of hazardous chemicals into the soil, air and water. She called the NIH news “a complicated mix of emotions,” CNN said. “We

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Community Asthma Engineering Complication 52

Maine Academy of Family Physicians

OCTOBER 22, 2023

6-week Medical Student Externship - Medical Student Externship Report – Molly Mann, MS2 2023 July – August "My externship experience consisted of shadowing Dr. Der Simonian at the Falmouth Family Medicine office and at the Maine Medical Center Mother Baby Unit. Der Simonian and her patients.

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Medical Student DO Family Medicine Patient-Centered 40

PEMBlog

JANUARY 16, 2025

Clin Toxicol (Phila) 2023; 61:453. Its evolved from its medical and industrial applications to a recreational substance with a significant cultural footprint. Further complicating matters is that each inhalant has its own special risks. Updated February 26, 2024. Accessed January 13, 2025. Intelligencer. English elite.

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Complication Patient-Centered Management Patients 52

GeriPal

FEBRUARY 8, 2024

2023 Dec 20:S1524-9042(23)00202-3. ” BJ: Well, I fall back on using physiology in the sort of medical sense. laughter] Eric: And part of that is this idea of, in hospice, sometimes we just try to medicate suffering away. We medicate that away. Pain Manag Nurs. doi: 10.1016/j.pmn.2023.11.004. 2023.11.004.

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GeriPal

MARCH 6, 2025

link] Toronto Star Feature [link] CityNews Toronto Feature [link] Psychosocial Interventions at PEACH In addition to medical care, PEACH also runs two key psychosocial interventions for our clients: PEACH Grief Circles Structured spaces for workers in the homelessness sector to process grief. those experiencing homelessness).

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Healthcare IT Community Illness 102

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. Alex 15:13 This is really complicated. Bill, welcome to the GeriPal podcast. Bill 00:53 Thank you, Alex. It happened to my mother.

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Patients IT Patient-Centered Hospital 98

FDA Law

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. 29, 2023) (“Basis”); NPRM at 44,603. 21 U.S.C. § 21 U.S.C. § 21 U.S.C. § NPRM at 44,601.

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New South Family Medicine and MedSpa

SEPTEMBER 17, 2019

The world of diets and dietary theories is complicated and can be overwhelming. Then take a moment to reflect on your unique plate. How closely does your current diet and lifestyle reflect the above plate? What similarities do you notice? Food has the power to regenerate the new you! Lets live healthy and whole, TOGETHER!”

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Common Sense Family Doctor

APRIL 25, 2025

While I'm grateful for subspecialists who alleviate pain, rescue patients who are unable to breathe on their own, manage complicated fractures, and replace worn-out hips and knees, the gap between the number of family doctors we need and the number we have keeps getting wider. growth in the U.S. growth in the U.S.

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DO Family Medicine Family Families 52

GeriPal

SEPTEMBER 14, 2023

The pneumonia could get treated, but I think geriatricians, actually, were well aware of iatrogenic complications of care and quality gaps, even well before the IOM reports of the late 1990s and the like. And we then did a bunch of work to develop medical criteria, to choose the right patients for hospital-at-home.

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PEMBlog

DECEMBER 4, 2024

Coverage with Selected Vaccines and Exemption Rates Among Children in Kindergarten — United States, 2023–24 School Year. Non medical exemptions accounted for over 93 percent of these exemptions. Aside from coughing forever, there’s some important complications you need to be aware of. This is the highest on record.

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IT Vaccination Diagnosis Complication 52

Physician's Weekly

JUNE 17, 2025

By the time Eric Tennant was diagnosed in 2023 with a rare cancer of the bile ducts, the disease had spread to his bones. 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. BRIDGEPORT, W.Va. —

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