FDA Law

JUNE 3, 2025

Houck We appreciate receiving feedback on our blog posts. We received a response to our post on the prescribing red flags indicating the likelihood of certain prescriptions filled by Walgreens pharmacies were invalid because they lacked a legitimate medical purpose or were not issued in the usual course of professional practice.

Clinical Practice 59

Clinical Practice Patient-Centered Patients Clinic 59

FDA Law

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. By Jeffrey N.

Medical 111

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. The post News & Notes: Spring 2025 first appeared on ABIM Blog.

Board-Certified Physicians 52

Board-Certified Physicians Board-Certified Provider Specialization 52

FDA Law

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the long anticipated final Clinical Decision Support Software Guidance (CDS Guidance), which replaces the revised draft guidance document from 2019.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

OCTOBER 24, 2023

By Dara Katcher Levy — Yesterday, FDA published a new Draft Guidance, “ Communications from Firms to Health Care Providers Regarding Scientific Information on Unapproved Uses of Approved/Cleared Medical Products Questions and Answers ” (SIUU Guidance or Draft Guidance).

Clinic 64

Clinic Clinical Practice Provider Utilities 64

ABIM

APRIL 24, 2025

Visit the ABIM Blog for reports of prior meetings. Chrostowski, DNP, APR-N, ANP-C , asked whether ABIM will offer continuing medical education (CME) credits through the LKA. Thousands of activities are eligible for both MOC and CME via a collaboration with the Accreditation Council for Continuing Medical Education at cmepassport.org.

Board-Certified 40

Board-Certified Board-Certified Physicians Community Government 40

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

Physician's Practice

JUNE 25, 2025

Reynolds Blog Video Neil Baum, MD, asks whether your patients are satisfied with their care and shows how a quick survey could make the difference. If your patients are unhappy with care then they probably won't come back to your practice. He has written ten books on practice management and the business of medicine.

Patients 52

Patients Private Practice Management Healthcare 52

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. JAMA Pediatr. Hosp Pediatr.

Patients 52

Patients Hospital Illness Management 52

GeriPal

MARCH 14, 2024

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. Nicole: Yeah, I think definitely delirium, but there are also a lot of medical conditions that can be specific to hospitalizations.

IT 124

IT Patient-Centered Hospital Individual 124

FDA Law

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

OCTOBER 2, 2024

I’ll dive into the latest clinical practice guidelines and discuss evidence-based approaches to diagnosis and treatment. Understanding dyspepsia and its clinical presentation. Join me as I scope out the nuances of gastroesophageal reflux and gastritis and provide practical insights for clinicians in the emergency setting.

Diagnosis 52

Diagnosis Management IT Patient-Centered 52

FDA Law

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.

Manufacturing 105

Manufacturing Management Clinical Practice Clinic 105

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

ABIM

JUNE 24, 2025

Visit the ABIM Blog for reports of prior meetings. The group discussed policy shifts and potential implications for graduate medical education and health equity. Outcomes are pending but the sponsors will report on the program as fellows begin to graduate, and track practice data as well.

Board-Certified 40

Board-Certified Board-Certified Physicians Government Community 40

ABIM

JUNE 11, 2025

Visit the ABIM Blog for reports of prior meetings. This is now being reviewed by the American Board of Medical Specialties, which oversees ABIM. ABIM’s website features expansive sections on research related to assessment and clinical outcomes. Community Practice in ABIM Governance* Erica N.

Board-Certified 52

Board-Certified Government Community Education 52

FDA Law

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.

Patient-Centered 75

Patient-Centered Clinical Practice Patients Individual 75

FDA Law

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.” hurricane) or public health emergency (e.g.,

Clinic 64

Clinic Supply Chain Clinical Practice Patient-Centered 64

ABIM

MAY 30, 2025

Visit the ABIM Blog for reports of prior meetings. Lieske, MD , raised concerns about how new government policies may affect international medical graduates and health equity work at ABIM. One notable trend was a higher representation of international medical graduates and osteopathic physicians in the specialty.

Board-Certified 40

Board-Certified Government Internal Medicine Private Practice 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

FDA Law

SEPTEMBER 10, 2023

Interventional studies are generally clinical investigations under the regulations and thus require an IND under 21 C.F.R. § An interesting addition in the final guidance is that it explains that the topics discussed “apply to any type of RWD, including data on products used in clinical practice under an emergency use authorization (EUA).”

Provider 108

Provider Patient-Centered Clinic Clinical Practice 108

FDA Law

NOVEMBER 29, 2022

CDC Clinical Practice Guideline for Prescribing Opioids for Pain — United States, 2022. We blogged on the 2016 guideline here in March 2016, and the proposed guideline here on March 18th). Expected clinical benefits should be weighed against risks before beginning therapy. MMWR Recomm Rep 2022;71(No. RR-3):1–95.

Patients 52

Patients Patient-Centered ER Individual 52

GeriPal

JANUARY 18, 2024

In particular, we talk about Katie’s and Jesica’s paper in NEJM titled “ Juggling Two Full-Time Jobs — Methadone Clinic Engagement and Cancer Care ,” which described the difficulty in managing cancer pain and methadone for opioid use disorder. And you wrote, actually, a beautiful GeriPal blog about it a while ago. What is it called?

Illness 136

Illness Patient-Centered Screening Clinic 136

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? Cartwright’s study influenced the equations that medical professionals still use to calculate the impact of various diseases on lung function. Health Aff Blog​. racial essentialism).

Clinical Practice 52

Clinical Practice Clinic Medical Education 52

GeriPal

FEBRUARY 9, 2023

Amber tells the moving story of how these findings led a clinical colleague, her chief, to question and change his behavior. As we’ve written about on GeriPal when we were a blog (a decade ago!) Amber: Well, simulation is pretending, so I think of the way I use simulation is in trying to simulate clinical care.

Patient-Centered 111

Patient-Centered Patients IT Healthcare 111

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.

IT 87

IT Patient-Centered Patients Medical 87