FDA Law Blog

FEBRUARY 27, 2025

Livornese As anticipated, the International Council for Harmonization (ICH) published the Good Clinical Practice (GCP) guideline E6(R3) Principles and Annex 1 on January 6, 2025. While ICH E6(R3) was still in the development phase, the FDA released a draft guidance in May 2023 in the form of the draft ICH E6(R3).

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Clinical Practice Clinic Government Management 88

Common Sense Family Doctor

MAY 1, 2025

A patient with a history of headaches is brought by ambulance to the emergency department for the abrupt onset of weakness and decreased sensation in their left arm and leg. A code stroke is called. Are these symptoms of an acute stroke or a stroke mimic , such as a hemiplegic migraine ?

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Primary Care Family Physician Clinical Practice Diagnosis 52

Medical Xpress

JANUARY 18, 2023

Researchers from UC San Francisco and Zuckerberg San Francisco General Hospital (ZSFG) reviewed the medical records of 26 stroke patients who identified as sexual and gender minorities and compared them with 78 age-matched stroke patients who were not sexual and gender minorities. Findings appear in Neurology Clinical Practice on Jan.

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Clinical Practice Hospital Clinic Patients 98

Physician's Weekly

JUNE 26, 2025

I have found explaining the pathophysiology of obesity (eg, the role of biology, genes , and systemic risk factors), addressing the lived experience related to weight bias, individualizing the intervention to match the child’s family needs, and focusing on building the patient/family agency for change helps with engagement.

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Sound Physicians

NOVEMBER 19, 2024

Great patient care starts with great clinician leadership. I am often asked about how Sound builds the next generation of clinical leaders. The expertise and thoughtfulness that our leaders bring to our patients, teams, and, most importantly, our hospital partners is not something that just happens.

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Hospital Telemedicine Clinic Management 52

The Clinical Problem Solvers

DECEMBER 16, 2020

Nwamaka Eneanya and Jennifer Tsai to discuss the limitations and harms of race-based medicine in clinical practice. Our guests explain how we can incorporate race-conscious medicine in clinical settings, medical education, and biomedical/epidemiological research to responsibly recognize and address the harms of racial inequality.

Clinic 52

Clinic Education Clinical Practice Patient-Centered 52

FDA Law Blog

MAY 13, 2024

FDA recognizes the potential of RWE to support regulatory submissions of medical devices and to inform benefit-risk analysis of such products, while assuring patients have timely access to devices. However, in our experience, there is a large gap between FDA’s lauding the value of RWE and practice.

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Medical Clinic Patients IT 111

FDA Law Blog

FEBRUARY 27, 2023

That emergency declaration is set to expire on May 11, 2023. While no “special registration” will yet be required to engage in telemedicine prescribing of controlled substances, DEA is proposing parameters to guide the practice of telemedicine encounters in a post-COVID world. 21 U.S.C. § 802(54)(D)(i).

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Telemedicine Telecommunication Telehealth Medical 59

Common Sense Family Doctor

MAY 30, 2025

A 2023 Cochrane for Clinicians article found similar benefits but also noted that for every 10,000 people screened, 363 unnecessary invasive tests are performed. Interventions included patient navigation, outreach calls, and decision aids; control groups received usual care or informational materials.

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Primary Care Screening Family Physician Family Medicine 59

FDA Law Blog

OCTOBER 11, 2023

Snow — On September 18, 2023, FDA published an updated, final iteration of guidance for immediate implementation entitled, “ Considerations for the Conduct of Clinical Trials of Medical Products During Major Disruptions Due to Disasters and Public Health Emergencies.” By James E. Valentine & Charles D.

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Clinic Supply Chain Clinical Practice Patient-Centered 64

ABIM

MAY 30, 2025

Expanding ABIM’s engagement with stakeholder communities such as early career physicians, specialty societies and patient-focused organizations. At the time of the spring 2025 meeting, ACGME had reviewed the proposal, which outlines clear roles for program directors and emphasizes both patient care and transplant knowledge.

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Board-Certified Government Internal Medicine Private Practice 40

GeriPal

FEBRUARY 9, 2023

For example, we spend the first half talking about a RCT simulation study of clinician verbal and non-verbal communication with a seriously ill patient with cancer. In one room the physician under study interacts with a white patient-actor, and in another room interacts with a Black patient-actor. Amber: Thank you guys.

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Patient-Centered Patients IT Healthcare 112

GeriPal

JULY 13, 2023

On that podcast he and collaborators tested a combined patient and clinician facing communication priming intervention to promote goals of care conversations. Randy died February 26, 2023. He really practiced what he preached. Randy Curtis was first author of the JAMA paper. We’ll have a link to the article on our notes.

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Patient-Centered IT Patients Hospital 84

The Clinical Problem Solvers

MAY 2, 2023

Gillette” Gillette-Pierce May 2, 2023 Summary: This episode highlights the psychosocial and cultural considerations for providing healthcare to immigrant and refugee populations. Refer to Good Sanctuary Doctoring for Undocumented Patients for more information. References Morris JE, Saadi A.

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Healthcare Provider Clinical Practice Clinic 52