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 ). However, in our experience, there is a large gap between FDA’s lauding the value of RWE and practice. Patients that use ESD undergo continuous 24/7 monitoring. By Jeffrey N.

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Medical Clinic Patients IT 111

ABIM

MAY 7, 2025

Specialties are each on their own review cycle, and several—including Advanced Heart Failure and Transplant Cardiology, Critical Care Medicine, Gastroenterology, Medical Oncology and Transplant Hepatology—are currently under review. If you receive an email with a survey asking for input on a blueprint, please take the time to respond.

Board-Certified Physicians 52

Board-Certified Physicians Board-Certified Provider Specialization 52

ABIM

APRIL 24, 2025

Visit the ABIM Blog for reports of prior meetings. Expanding ABIM’s engagement with stakeholder communities such as early career physicians, specialty societies and patient-focused organizations. Chrostowski, DNP, APR-N, ANP-C , asked whether ABIM will offer continuing medical education (CME) credits through the LKA.

Board-Certified 40

Board-Certified Board-Certified Physicians Community Government 40

PEMBlog

SEPTEMBER 27, 2023

This is a blog post designed to disseminate the important work of Choosing Wisely , an initiative of the the American Board of Internal Medicine Foundation, the goal of which is the spark conversations between clinicians and patients about what tests, treatments, and procedures are needed – and which ones are not.

Patients 52

Patients Illness Hospital Management 52

FDA Law Blog

OCTOBER 10, 2022

Javitt — On September 28, 2022, the FDA issued the long anticipated final Clinical Decision Support Software Guidance (CDS Guidance), which replaces the revised draft guidance document from 2019. You can find our preliminary blog post on the release of this guidance here , and our blog posts on the draft CDS guidances here and here.

Clinic 52

Clinic Medical Provider Patients 52

FDA Law Blog

FEBRUARY 27, 2023

The Ryan Haight Act was enacted to address the legal “grey area” in which prescribers and pharmacies operated via the creation of two new statutory requirements: 1) the at least one “in-person” medical evaluation requirement for prescribing practitioners, 21 U.S.C. § 829(e); and 2) the modified registration requirement for online pharmacies.

Telemedicine 59

Telemedicine Telecommunication Telehealth Medical 59

PEMBlog

AUGUST 30, 2023

This is a blog post and a podcast episode designed to disseminate the important work of Choosing Wisely , an initiative of the the American Board of Internal Medicine Foundation, the goal of which is the spark conversations between clinicians and patients about what tests, treatments, and procedures are needed – and which ones are not.

Asthma 52

Asthma Electronics Utilities Clinical Practice 52

GeriPal

MARCH 14, 2024

This simple challenge was focused on putting ourselves in the shoes of our patients with dysphagia who are prescribed thickened liquids. Eric: Well, before we talk about dysphagia and revisit it, which is also interesting, because this is our first podcast, I think on dysphagia, but we’ve talked about it before on GeriPal, in our blog.

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IT Hospital Patient-Centered Individual 124

PEMBlog

OCTOBER 2, 2024

I’ll make the important distinction between gastritis – which is diagnosed only via endoscopy – and dyspepsia, the term best used to describe the symptoms many patients experience. I’ll dive into the latest clinical practice guidelines and discuss evidence-based approaches to diagnosis and treatment.

Diagnosis 52

Diagnosis Management IT Patient-Centered 52

FDA Law Blog

MARCH 6, 2025

Lenz, Principal Medical Device Regulation Expert & Lisa M. Both guidance documents recommend data management practices for collecting data for use in developing, tuning, and testing an artificial intelligence model and making changes to said model. By Adrienne R. FDA notes the use of data collected outside the U.S.

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Manufacturing Management Clinical Practice Clinic 105

FDA Law Blog

MARCH 17, 2022

Houck — The Centers for Disease Control and Prevention (“CDC”) issued a voluntary practice guideline on opioid prescribing for clinicians treating chronic pain five years ago. (We We blogged on the final 2016 guideline here on March 17, 2016). Proposed 2022 CDC Clinical Practice Guideline for Prescribing Opioids, 87 Fed.

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Patient-Centered Clinical Practice Patients Individual 75

ABIM

JUNE 4, 2025

Representatives from the American Association of Clinical Endocrinology (AACE), the Association of Program Directors in Endocrinology, Diabetes and Metabolism (APDEM) and the Endocrine Society joined for a portion of the meeting*. Visit the ABIM Blog for reports of prior meetings. Community Practice in ABIM Governance* Erica N.

Diabetes 52

Diabetes Board-Certified Telehealth Government 52

FDA Law Blog

NOVEMBER 29, 2022

CDC Clinical Practice Guideline for Prescribing Opioids for Pain — United States, 2022. CDC received some 5,500 comments from patients, caregivers, clinicians and interested organizations to the proposed guideline update it issued in February. Dowell D, Ragan KR, Jones CM, Baldwin GT, Chou R., MMWR Recomm Rep 2022;71(No.

Patients 52

Patients Patient-Centered ER Individual 52

ABIM

JUNE 11, 2025

Visit the ABIM Blog for reports of prior meetings. Expanding ABIM’s engagement with stakeholder communities such as early career physicians, specialty societies and patient-focused organizations. This is now being reviewed by the American Board of Medical Specialties, which oversees ABIM.

Board-Certified 52

Board-Certified Government Community Education 52

ABIM

JUNE 24, 2025

Visit the ABIM Blog for reports of prior meetings. Expanding ABIM’s engagement with stakeholder communities such as early career physicians, specialty societies and patient-focused organizations. The group discussed policy shifts and potential implications for graduate medical education and health equity.

Board-Certified 40

Board-Certified Board-Certified Physicians Government Community 40

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.

IT 126

IT Patient-Centered Illness Education 126

ABIM

MAY 30, 2025

Visit the ABIM Blog for reports of prior meetings. Expanding ABIM’s engagement with stakeholder communities such as early career physicians, specialty societies and patient-focused organizations. Lieske, MD , raised concerns about how new government policies may affect international medical graduates and health equity work at ABIM.

Board-Certified 40

Board-Certified Government Internal Medicine Private Practice 40

FDA Law Blog

SEPTEMBER 10, 2023

In contrast, as the guidance explains, a non-interventional study (also referred to as an observational study) is a type of study in which patients received the marketed drug of interest during routine medical practice and are not assigned to an intervention according to a protocol.

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Provider Patient-Centered Clinic Patients 108

GeriPal

JANUARY 18, 2024

We start off the conversation by talking about whether patients with cancer and cancer pain are really that different, and their paper that was just published on January 11 th in JAMA Oncology showing that substance use disorder is not uncommon in individuals with cancer. So, I don’t think we should have these silos. What is it called?

Illness 136

Illness Patient-Centered Screening Clinic 136

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.

Patient-Centered 111

Patient-Centered Patients IT Healthcare 111

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.”

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Clinic Supply Chain Clinical Practice Patient-Centered 64

The Clinical Problem Solvers

NOVEMBER 16, 2020

37:50​ Race vs. ancestry vs genetics–implications for research and clinical practice 52:02 ​What can we start doing tomorrow? How is racism causing the outcomes that I am seeing in my patient? Ignoring race and racism does not negate the profound impact that race and racism have on our BIPOC patients’ health.

Clinical Practice 52

Clinical Practice Clinic Medical Education 52

GeriPal

MARCH 20, 2025

Summary Transcript CME Summary Eric and Alex have featured discussions about complex bioethical concepts around caring for people at the end of life, including voluntarily stopping eating and drinking ( VSED ), and multiple episodes about the ethical issues surrounding medical aid in dying ( MAID ). Alex 00:14 We have a very full house today.

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IT Patient-Centered Patients Medical 88