FDA Law Blog

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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Patient-Centered Medical Patients IT 59

FDA Law Blog

AUGUST 22, 2023

On the heels of a nuanced and more complicated Warning Letter addressing CFL claims and statistical presentations comes a new Untitled Letter from OPDP going back to its roots ! Six weeks after the NAD/ViiV brouhaha, and about a year since its last letter, OPDP issued its first letter of 2023, citing misleading claims about efficacy and risk.

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Healthcare Professional Healthcare IT Complication 40

PEMBlog

AUGUST 20, 2024

2023; 187:109792. ECPR involves using ECMO (Extracorporeal Membrane Oxygenation) to take over heart and lung functions, offering a last-resort option that is becoming more common in large pediatric hospitals. Establishing an ECPR program requires robust infrastructure, multidisciplinary teamwork, and extensive training. Am Heart J.

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Patient-Centered Hospital Patients IT 52

PEMBlog

APRIL 20, 2023

Rather, it can change the bleeding phenotype from severe hemophilia to mild hemophilia – thus potentially reducing the risk of complications. Many ED providers may get a factor VIII level to decide if a patient needs factor treatment if a patient is already on “prophylaxis.” How to know if a patient is on it?

Individual 52

Individual Patient-Centered Patients IT 52

FDA Law Blog

FEBRUARY 28, 2023

FDA announced on October 3, 2022 that the voluntary electronic Submission Template And Resource (eSTAR) templates would be required beginning October 1, 2023, as we blogged about here. There are additionally places to provide attachments for test reports and other supporting documents. Learnings on how eSTAR works Starting Too Early.

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Provider Electronics IT Specialization 52

Doctor On Demand

APRIL 28, 2025

Urgent care clinics provide quick diagnoses and treatments, including antibiotics if needed. Most sore throats are common cases, so it can be hard to know when to seek urgent care or when to just rest at home. Swollen neck Neck swelling may suggest an infection spreading into deeper tissues.

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Medical Xpress

JUNE 16, 2025

But what we observed was much more complicated." This cluster of about 20,000 to 40,000 neurons functions like a central watch, coordinating the timing of body functions to follow the 24-hour day. When we cross time zones and experience jet lag, it happens because our internal clock remains set to the old time zone.

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Provider Medical Complication Diabetes 109

Medical Xpress

JUNE 16, 2025

The goal is to support clinical trials and bring in another $50 million in private investment to help ibogaine win approval from the U.S. Food and Drug Administration (FDA). The process could take years. Ibogaine is made from the root of a plant found in Africa. It has been banned in the U.S. Former Texas Gov.

Mental Health 52

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. So, this year, “An Arm and a Leg” asked listeners: What strategies have you used when you’ve been struck by pharmacy sticker shock? He left without it.

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GeriPal

FEBRUARY 8, 2024

2023 Dec 20:S1524-9042(23)00202-3. It is the CME activity provider’s responsibility to submit participant completion information to ACCME for the purpose of granting ABIM MOC credit. Hospital Chaplains, Spirituality, and Pain Management: A Qualitative Study. Pain Manag Nurs. doi: 10.1016/j.pmn.2023.11.004. 2023.11.004. PMID: 38129210.

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IT Families Family Physicals 137

PEMBlog

JANUARY 16, 2025

Learn how to recognize and manage cases in the emergency department, ask the right questions to uncover inhalant use, and provide critical resources for prevention and support. Clin Toxicol (Phila) 2023; 61:453. Formulate effective strategies for identifying, managing, and preventing inhalant misuse in pediatric patients.

Complication 52

Complication Patient-Centered Management Patients 52

GeriPal

MARCH 6, 2025

link] PEACH Good Wishes Program A program that provides meaningful gifts for unhoused individuals who are terminally ill. So we did a podcast on aging and homelessness with Margot Kushel in 2023. Today we discuss: What is the best terminology? Homelessness? Marginally housed? What makes it rewarding? those experiencing homelessness).

Healthcare 100

Healthcare IT Community Illness 100

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.

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Medical Student Family Medicine DO Patient-Centered 40

GeriPal

SEPTEMBER 5, 2024

Louise 05:02 Yes, well, I don’t know about 2024, but in 2023, yes, it could happen. But before we go into all of that, I think, Bill, you have a song request for Alex. Bill 01:52 I do. Bill 01:53 Alex asked me for a song that was resonating in my head at the time, and it would be Guy Clark’s song, T he Cape. I’ll make sure.

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Patients IT Patient-Centered Hospital 98

New South Family Medicine and MedSpa

SEPTEMBER 17, 2019

The world of diets and dietary theories is complicated and can be overwhelming. Eating fruit provides excellent health benefits and is part of a healthy plate. Fruits provide nutrients vital for health and maintenance of your body. Fiber containing foods such as fruits help provide a feeling of fullness with fewer calories.

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Referral DO Family Medicine Primary Care 40

FDA Law Blog

MAY 21, 2024

The Attorney General also released DOJ’s Office of Legal Counsel (“OLC”) opinions providing the rationale and support for the NPRM. 29, 2023) (“Basis”); NPRM at 44,603. and lacked accepted safety for use under medical supervision. 21 U.S.C. § 21 U.S.C. § Schedules of Controlled Substances: Rescheduling of Marijuana, 89 Fed.

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Physicals Medical Clinic Emergency Room 69

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.

Family Medicine 52

Family Medicine DO Family Families 52

GeriPal

SEPTEMBER 14, 2023

And we would provide ongoing longitudinal care to them in the home, much like the Mount Sinai Visiting Doctors programs, and other programs like that. In addition to discussing these outcomes, we also discuss: The history of the hospital-at-home movement. How is it financed and what comes next? Alex: Good challenge. Thanks, Bruce. Eric: Okay.

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Hospital Patient-Centered Supply Chain IT 115

PEMBlog

DECEMBER 4, 2024

This episode also covers what healthcare providers need to know about post-exposure prophylaxis, respiratory precautions, and managing occupational exposures. Coverage with Selected Vaccines and Exemption Rates Among Children in Kindergarten — United States, 2023–24 School Year. Available at: [link] Accessed December 3, 2024.

IT 52

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. A North Carolina bill would require doctors who review patient appeals to have practiced medicine in the same specialty as the patient’s provider. “They’re, like, not accountable to anyone.”

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Insurance Patients Behavioral Health Services Diagnose 52