FDA Law Blog

APRIL 23, 2023

This Draft Guidance focuses on the use of patient-level data from other clinical trials or from RWD sources. The Draft Guidance recommends that, where possible, the outcome should be assessed by individuals blinded to treatment status, which may require re-adjudication of externally controlled data.

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FDA Law Blog

JUNE 27, 2024

After issuing an Order to Show Cause and Immediate Suspension of Registration in September 2022, and an administrative hearing in March 2023, DEA adopted the hearing Administrative Law Judge’s (“ALJ’s”) Recommended Decision to revoke Coconut Grove’s registration based on the public interest factors of 21 U.S.C. 21 C.F.R. §§ 1306.04(a),

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Insurance Patients Utilities Chronic Condition 52

GeriPal

NOVEMBER 9, 2023

Hot off the presses RCT in JAMA October 2023: Study that looks at 1000 female resident physicians at 26 sites that showed that coaching improved each outcome assessed (burnout, moral injury, imposter syndrome, self-compassion, and flourishing). AlexSmithMD 1. Beth, welcome to GeriPal. Beth: Thank you. Greg, welcome to GeriPal.

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Today's Hospitalist

JUNE 7, 2025

They presented a rapid clinical update Webinar in May 2025 hosted by the Society of Hospital Medicine. ” All anti-obesity medications, even the earlier generation of these drugs—which include orlistat, phentermine, phentermine/topiramate (Qsymia) and naltrexone/bupropion (Contrave)—cause clinically significant weight loss.

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Hospital Management Diabetes Patients 66

Doctor On Demand

APRIL 28, 2025

Urgent care clinics provide quick diagnoses and treatments, including antibiotics if needed. In fact, most sore throat symptoms resolve in three days for 60-70% of patients, according to March 2025 UpToDate, an evidence-based clinical decision support system used by healthcare professionals. Is my sore throat contagious?

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PEMBlog

MARCH 27, 2024

She is a member of the Clinical Genome Resource Inborn Errors of Metabolism (IEM) Clinical Domain Working Group, where as a biocurator she assesses the pathogenicity of variants in IEM-associated genes to facilitate expedited genetic diagnosis for IEMs. Updated 2023 Jul 17]. References Jeanmonod R, Asuka E, Jeanmonod D.

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FDA Law Blog

JULY 9, 2024

Livornese — The Food and Drug Omnibus Reform Act (“FDORA”), enacted in December 2022, added a requirement that sponsors submit Diversity Action Plans (“DAPs”) for certain clinical studies involving drugs, biological products, or devices (codified at 21 U.S.C. § 355(z)(3) and 21 U.S.C. 360j(g)(9)(A)). intended use population.

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Clinic Provider Individual IT 59

GeriPal

JANUARY 16, 2025

These individuals may become unrepresented, meaning they lack the capacity to make a specific medical decision, do not have an advance directive for that decision, and do not have a surrogate to help. How should we care for unrepresented individuals in inpatient and outpatient settings? Why not use the older term unbefriended?

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Patient-Centered IT Patients Healthcare 109

GeriPal

MAY 8, 2025

Summary Transcript CME Summary Weve covered psychedelics on the podcast beforefirst in 2019 with Ira Byock, where we explored their potential role in medicine , and then again in 2023 with Stacy Fischer, Brian Anderson, and Theora Cimino, focusing on the reasons to approach psychedelic use in patients with caution. James 00:32 Good afternoon.

Illness 107

Illness IT Patient-Centered Patients 107

PEMBlog

JANUARY 16, 2025

Well dive into the clinical presentations, including acute and chronic symptoms, the dangers of sudden sniffing death, and the specific risks associated with nitrites, hydrocarbons, and nitrous oxide. Clin Toxicol (Phila) 2023; 61:453. I would consult a toxicologist because I know that this is rare. Updated February 26, 2024.

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Complication Patient-Centered Management Patients 52

GeriPal

MARCH 24, 2023

JAMA IM 2023 A shout-out to my NPR episode on 1A titled the “State of Hospice Care” DISCLAIMER While we filmed in Montreal during the Annual Assembly, all opinions expressed in this podcast are independent of AAHPM and HPNA, or the Annual Assembly. JAMA IM 2021 Hospice Acquisitions by Profit-Driven Private Equity Firms. JAMA Health Forum.

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Physicians News Digest

MAY 12, 2025

31 that a New York physician had been indicted for shipping abortion medications to a woman in Louisiana, it stoked fear across the network of doctors and medical clinics who engage in similar work. It was unclear when those tests would come, and would it be against an individual provider or a practice or organization?” It’s scary.

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PEMBlog

APRIL 4, 2025

The episode emphasizes thoughtful, individualized care in the context of rising vaccine hesitancy and declining immunization rates. Unfortunately, timely clinical question, what do we do with the UN or under vaccinated child who presents to the emergency department with fever? So as of the 2023-24 school year, about 3.3%

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Vaccination Illness IT Clinic 68

GeriPal

JULY 20, 2023

See the AAHPM Legislative Action Center [link] Write to the DEA, with guidance from AAHPM’s comments to the DEA March 2023. But in California where I practice medical aid and dying is legal and similar to other issues that are controversial in some places, many physicians do not prescribe or do visits for medical aid and dying consultations.

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