FDA Law Blog

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By Dara Katcher Levy — Yesterday, FDA published a new Draft Guidance, “ Communications from Firms to Health Care Providers Regarding Scientific Information on Unapproved Uses of Approved/Cleared Medical Products Questions and Answers ” (SIUU Guidance or Draft Guidance).

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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. By Jeffrey N.

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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. This information will be open for a public comment period for societies to weigh in on the final blueprint.

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Board-Certified Physicians Board-Certified Provider Specialization 52

ABIM

JUNE 12, 2025

Upgrades to the ABIM website and Physician Portal for 2025, designed to make it easier for both physicians and the public to find information. The ABIM Council approved the pilot earlier this year and submitted it to the American Board of Medical Specialties, the final approval stage before implementation.

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Medical Xpress

FEBRUARY 21, 2023

During the initial recovery phase, clinicians struggle to collect information about sleep patterns, mental health, and other symptoms from their patients. Measuring the patient's perspective of recovery after cardiac surgery is challenging.

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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.

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FDA Law Blog

JUNE 3, 2025

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. Gulf Med Pharmacy; Decision and Order, 86 Fed. Recommendation 1.

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GeriPal

JANUARY 23, 2025

Summary Transcript CME Summary Its another deprescribing super special on today’s GeriPal Podcast, where we delve into the latest research on deprescribing medications prescribed to older adults. Today, we explore four fascinating studies highlighting innovative approaches to reducing medication use and improving patient outcomes.

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ABIM

APRIL 24, 2025

Upgrades to the ABIM website and Physician Portal for 2025 designed to make it easier for both physicians and the public to find information. Chrostowski, DNP, APR-N, ANP-C , asked whether ABIM will offer continuing medical education (CME) credits through the LKA.

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The Clinical Problem Solvers

OCTOBER 18, 2022

Correctional officers act as gatekeepers, deciding who does and does not need medical care. This means that people who are incarcerated are often not believed when they say they need medical care. Calac, Michelle Ogunwole MD, PhD, Ayana Watkins, Chioma Onuoha, Naomi F. Fields MD, Victor A.

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Healthcare Professional Healthcare Patient-Centered Mental Health 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. Criterion 2 : Non-Device CDS software functions display, analyze or print medical information about a patient or other medical information.

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GeriPal

JUNE 20, 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.

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Physician's Practice

JUNE 25, 2025

These videos are 5 to 10 minutes in length and will provide practical ideas and suggestions that have been tested in his practice or used by other physicians that significantly improve the efficiency and productivity of their medical practices. He has written ten books on practice management and the business of medicine.

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PEMBlog

AUGUST 30, 2023

While no validated clinical prediction rule is available yet to determine which children should receive a CXR, we do know that the presence of bacterial pneumonia is uncommon in otherwise healthy, immunized children with usual presentations of asthma, bronchiolitis and croup. But it’s just a CXR right?

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Physician's Practice

JUNE 26, 2025

Reynolds Feature Video Introducing Neil Baum, MD, Professor of Clinical Urology at Tulane Medical School in New Orleans, Louisiana, and the author of multiple books. Have you ever wondered who is giving all the advice on Physicians Practice ? Now is your chance to get to know them.

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GeriPal

JULY 19, 2024

We didn’t have medications that were effective with a few side effects. I heard this beautiful thing the other day, which was to an electronic medical record, I am not a whole person. As my colleague mentioned, I am not a whole person to my medical record, I am a collection of codes. They have complex medical regimens.

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GeriPal

JANUARY 12, 2023

Alex: And we’re delighted to welcome back to the GeriPal Podcast, Stephanie Rogers, who’s a geriatrician and medical director of UCSF’s, age-friendly health systems. And yeah, it just clicked for me like yes, this is how I like to practice medicine. Kellie, welcome to the GeriPal Podcast. Kellie: Thank you so much.

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Hospital Patient-Centered IT Nurse Practitioner 100

GeriPal

MARCH 14, 2024

Nicole: Yeah, I think definitely delirium, but there are also a lot of medical conditions that can be specific to hospitalizations. Are medications part of that, too? So, a lot of medications, you can see the secondary effects of dysphagia causing those, as well. We’ll also look at cognitive status, medications.

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GeriPal

MAY 5, 2022

Was there any mention about the impact that hearing loss has in communication or what we should do about it in clinical practice? And when you think about that, they’re hearing pieces of the information and their brain is trying to make sense of it. It’s because they literally couldn’t access the information.

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Annals of Family Medicine

NOVEMBER 20, 2024

Context: We previously reported on the effectiveness of PINCER at reducing hazardous prescribing in primary care in a cluster randomised trial, and the subsequent roll out of the intervention in one region of England; PINCER has now been rolled out nationally to over 2,800 general practices in England.

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GeriPal

JUNE 12, 2025

I was really fascinated not only with the medical side of things, but some of the. I knew I wanted to do palliative medicine pretty early Even in medical school. There were a number of opportunities to be involved in medical oncology and doing medical oncology rotations as a medical student, as an internal medicine residential.

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Annals of Family Medicine

NOVEMBER 20, 2024

Introduction International Medical Graduates (IMG) are an essential part of the international physician workforce, and exploring the predictors of success and failure for IMGs could help inform international and national physician labour workforce selection and planning.

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Medical Clinical Practice Patients Clinic 130

ABIM

JUNE 4, 2025

Upgrades to the ABIM website and Physician Portal for 2025 designed to make it easier for both physicians and the public to find information. See the discussion on the Special Consideration IMG (International Medical Graduates) Pilot Pathway below.)

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GeriPal

FEBRUARY 20, 2025

Thats my main take-home point after learning from our three guests today when talking about trauma-informed care, an approach that highlights key principles including safety, trustworthiness, peer support, collaboration, empowerment, and cultural sensitivity. Eric 00:15 And we have three guests to help us talk about trauma informed care.

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ABIM

JUNE 11, 2025

Upgrades to the ABIM website and Physician Portal for 2025 designed to make it easier for both physicians and the public to find information. This is now being reviewed by the American Board of Medical Specialties, which oversees ABIM. The group discussed some of Dr. McDonald’s updates in greater detail.

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ABIM

JUNE 24, 2025

Upgrades to the ABIM website and Physician Portal for 2025, designed to make it easier for both physicians and the public to find information. The group discussed policy shifts and potential implications for graduate medical education and health equity.

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Board-Certified Board-Certified Physicians Government Community 40

FDA Law Blog

MARCH 6, 2025

Lenz, Principal Medical Device Regulation Expert & Lisa M. Although bias may be difficult to eliminate completely, FDA recommends that manufacturers, as a starting point, ensure that the test data sufficiently represents the intended use (target) population of a medical device. By Adrienne R.

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FDA Law Blog

MARCH 17, 2022

Proposed 2022 CDC Clinical Practice Guideline for Prescribing Opioids, 87 Fed. et al, CDC Clinical Practice Guideline for Prescribing Opioids-United States, 2022, CDC. CDC Clinical Practice Guideline, 10. Clinicians should not dismiss patients on the basis of PDMP information. 7,838 (Feb.

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ABIM

MAY 30, 2025

Upgrades to the ABIM website and Physician Portal for 2025 designed to make it easier to find information for both physicians and the public. Lieske, MD , raised concerns about how new government policies may affect international medical graduates and health equity work at ABIM.

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GeriPal

MARCH 9, 2023

FDA is considering approval, shifting away from Schedule I restrictions, paving the way for use in clinical practice. Brian: For the use of substances like psilocybin and LSD in medical care, or at least in investigational treatments, I like to call it psychedelic therapy. Are we talking about hallucinogenics? Or does it?

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GeriPal

JUNE 27, 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.

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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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FDA Law Blog

NOVEMBER 29, 2022

CDC Clinical Practice Guideline for Prescribing Opioids for Pain — United States, 2022. Guideline opioid use recommendations “are not intended to be used as an inflexible, rigid standard of care; rather, they are intended to be guideposts to help inform clinician-patient decision-making.” MMWR Recomm Rep 2022;71(No. RR-3):1–95.

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Patients Patient-Centered ER Individual 52

GeriPal

APRIL 4, 2024

The Cruzan ruling led to a flood of interest in Advance Directives, and eventually to the Patient Self Determination Act, which mandates provision of information about advanced directives to all hospitalized patients. Other states set lower bars, including oral assignment of surrogate decision-makers.

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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.

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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. But the cancer specific databases just don’t have this information. Katie: Yeah.

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GeriPal

OCTOBER 10, 2024

Alex 01:23 And we’re delighted to welcome DorAnne Donesky, who is a palliative care nurse practitioner at Queen of the Valley Medical center in Napa and professor emeritus at the UCSF School of Nursing. So this is a practical, really basic idea that can be applied to clinical practice. DorAnne, welcome to GeriPal.

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