FDA Law Blog

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

ABIM

JUNE 12, 2025

Visit the ABIM Blog for reports of prior meetings. The questionnaire gathers information about clinical work and practice patterns, and ABIM uses the information to help update exam blueprints, develop policies for initial certification and MOC, and ensure adequately diverse representation of the profession in research.

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FDA Law Blog

OCTOBER 24, 2023

Previous iterations of this guidance from 2009 and 2014 (blogged on here and here ) were known as Good Reprint Practices (GRP). Throughout the SIUU Guidance, FDA refers to studies and analyses , suggesting that publications may cover more than a description of an adequate and well-controlled clinical trial.

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Clinic Clinical Practice Provider Utilities 64

FDA Law Blog

MAY 13, 2024

FDA has even gone so far as to maintain that the “real-life clinical performance of a medical product might be more clearly demonstrated through RWD/RWE because a controlled clinical trial often cannot evaluate all applications of a product in clinical practice across the full range of potential users.”

Medical 111

Medical Clinic Patients IT 111

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the long anticipated final Clinical Decision Support Software Guidance (CDS Guidance), which replaces the revised draft guidance document from 2019.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

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Clinic Medical Provider Patients 52

ABIM

MAY 7, 2025

Read Full Article Close Article Physicians provide valuable feedback on ABIM programs and policies Physicians play a critical role in shaping ABIM’s programs, ensuring they remain relevant, fair and aligned with the realities of modern clinical practice. The post News & Notes: Spring 2025 first appeared on ABIM Blog.

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FDA Law Blog

JUNE 10, 2024

BIMO inspections can consist of on-site inspections, data audits, and remote regulatory assessments of nonclinical laboratories, clinical investigators, sponsors, contract research organizations (CROs), bioequivalence facilities, institutional review boards (IRBs), and postmarketing surveillance.

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Provider Electronics Clinical Practice Management 111

ABIM

APRIL 24, 2025

Visit the ABIM Blog for reports of prior meetings. The questionnaire gathers information about clinical work and practice patterns, and ABIM uses the information to help update exam blueprints, develop policies for initial certification and MOC, and ensure adequately diverse representation of the profession in research.

Board-Certified 40

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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.

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Asthma Electronics Utilities Clinical Practice 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 Illness Hospital 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. I think someone has a song request for Alex. Raele: I do. I have one. Change by Blind Melon. Eric: Why did you choose this? Eric: Fancy.

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IT Patient-Centered Hospital Individual 125

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. June 25, 2025 By Neil Baum, MD Fact checked by Keith A. About Neil Baum, M.D.

Patients 52

Patients Private Practice Management Healthcare 52

FDA Law Blog

FEBRUARY 27, 2023

Comments, including data from research and clinical practice, that provides evidence that an alternate maximum day supply (other than the proposed 30-day supply). Proposed practitioner recordkeeping obligations. Additional safeguards or flexibilities that should be considered with respect to the rule.

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

Common Sense Family Doctor

MAY 30, 2025

Barriers to implementing findings from lung cancer screening trials into typical clinical practice include the nonrepresentative nature of research participants (younger, healthier, and less racially and geographically diverse than the target populations) and the superior infrastructure and clinical support available to them.

Primary Care 59

Primary Care Screening Family Physician Family Medicine 59

FDA Law Blog

MARCH 6, 2025

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. population due to differences in demographics, practice of medicine, or standard of care. The DCP may also define the sources of the data (e.g.,

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. The following is a summary of the spring meeting.

Diabetes 52

Diabetes Board-Certified Telehealth Government 52

ABIM

JUNE 24, 2025

Visit the ABIM Blog for reports of prior meetings. The questionnaire gathers information about clinical work and practice patterns, and ABIM uses the information to help update exam blueprints, develop policies for initial certification and MOC, and ensure adequately diverse representation of the profession in research.

Board-Certified 40

Board-Certified Board-Certified Physicians Government Community 40

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

Clinic 64

Clinic Supply Chain Clinical Practice Patient-Centered 64

ABIM

JUNE 11, 2025

Visit the ABIM Blog for reports of prior meetings. Some members of the Specialty Board were interested in the LKA experience, participant survey results—particularly responses about fairness—and how LKA performance data might reflect on clinical outcomes. The following is a summary of the spring meeting.

Board-Certified 52

Board-Certified Government Community Education 52

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

MAY 30, 2025

Visit the ABIM Blog for reports of prior meetings. Reddy, MPH, Senior Research Associate for ABIM, reviewed aggregate data gathered so far related to nephrologists, including practice setting, practice size and physician ownership of practices. Learn More Subscribe to the ABIM Blog to stay on top of the latest news.

Board-Certified 40

Board-Certified Government Internal Medicine Private Practice 40

GeriPal

FEBRUARY 29, 2024

But when we have people in rural areas of California, so we don’t know our clinical site, we go from San Francisco all the way to the Northern California border, super rural areas. I actually wrote a blog post about this when we were a blog. We were a blog? But I remember having a conversation with them.

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IT Patient-Centered Illness Education 127

FDA Law Blog

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).”

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Provider Patient-Centered Clinic Patients 108

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 137

Illness Patient-Centered Screening Clinic 137

FDA Law Blog

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

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? Given that there is no standard definition of race, its imprecision does not meet the standards of clinical medicine. Health Aff Blog​. racial essentialism). 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 112

Patient-Centered Patients IT Healthcare 112

GeriPal

MARCH 20, 2025

Alex 00:48 And we’re delighted to welcome back Josh Briscoe, who’s a palliative care doc at the Durham VA Medical center in Duke and blogs at Notes from a Family Meeting. I was part of a writing group that wrote clinical guidelines for VSET for voluntarily stopping eating and drinking. Thaddeus 00:46 Thank you.

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IT Patient-Centered Patients Medical 89

PEMBlog

JANUARY 17, 2024

Camargo, Clinical Trial: Comparative Effectiveness of Cephalexin Plus Trimethoprim-Sulfamethoxazole Versus Cephalexin Alone for Treatment of Uncomplicated Cellulitis: A Randomized Controlled Trial, Clinical Infectious Diseases, Volume 56, Issue 12, 15 June 2013, Pages 1754–1762, [link] Liu C, Bayer A, Cosgrove SE, et al.

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IT Patients Diagnosis Clinic 59