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

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

FDA Law Blog

OCTOBER 10, 2022

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. Criterion 3 : Non-Device CDS software functions are intended for the purpose of supporting or providing recommendations about a patient’s care to a health care professional (HCP) user.

Clinic 52

Clinic Medical Provider Patients 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. for bronchiolitis and 1.5%

Patients 52

Patients Illness Hospital Management 52

FDA Law Blog

FEBRUARY 27, 2023

The rule would permit a practitioner using a telemedicine encounter to prescribe controlled substances without an in-person visit under various situations involving both an audio-visual telehealth evaluation, or an in-person evaluation performed by a “referring” provider. Proposed practitioner recordkeeping obligations.

Telemedicine 59

Telemedicine Telecommunication Telehealth Medical 59

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.

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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 Blog

SEPTEMBER 10, 2023

Even though an IND is not required, this guidance is intended to provide recommendations for sponsors to follow for using RWE from such studies for regulatory decision-making. In all cases, applicable requirements regarding informed consent (21 CFR Part 50) and Institutional Review Board review (21 CFR Part 56) must be met.

Provider 108

Provider Patient-Centered Clinic Patients 108

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. If data are excluded because of data quality issues, the rationale and criteria for the exclusions should be documented in the DCP.

Manufacturing 105

Manufacturing Management Clinical Practice Clinic 105

ABIM

JUNE 24, 2025

Visit the ABIM Blog for reports of prior meetings. Since 2013, ABIM Specialty Boards have been required to include at least one physician member primarily engaged in community practice, defined broadly in applications as “clinical practice in a non-university, community setting.”

Board-Certified 40

Board-Certified Board-Certified Physicians Government Community 40

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

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.

Patient-Centered 75

Patient-Centered Clinical Practice Patients Individual 75

ABIM

MAY 30, 2025

Visit the ABIM Blog for reports of prior meetings. Since 2013, ABIM Specialty Boards have been required to include at least one physician member primarily engaged in community practice, defined broadly in applications as “clinical practice in a non-university, community setting.” Learn more.

Board-Certified 40

Board-Certified Government Internal Medicine Private Practice 40

ABIM

JUNE 11, 2025

Visit the ABIM Blog for reports of prior meetings. Since 2013, ABIM Specialty Boards have been required to include at least one physician member primarily engaged in community practice, defined broadly in applications as “clinical practice in a non-university, community setting.”

Board-Certified 52

Board-Certified Government Community Education 52

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 Blog

OCTOBER 11, 2023

In general, both of these guidances provide recommendations for sponsors to consider and analyze when a disaster (e.g., pandemic) strikes, causing a major disruption to the conduct of a clinical trial. protecting the clinical trial’s goal of continuing to produce valid data to support eventual regulatory decision-making).

Clinic 64

Clinic Supply Chain Clinical Practice Patient-Centered 64

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). These should provide the healthcare industry with more useful guidance to be incorporated in patient treatment and care. RR-3):1–95.

Patients 52

Patients Patient-Centered ER Individual 52

GeriPal

JANUARY 18, 2024

And you wrote, actually, a beautiful GeriPal blog about it a while ago. Anybody with a DEA and… I should be very careful because this is different for physicians and advanced practice providers. And Katie, as an advanced practice provider, is much better than I am at explaining how this works. Katie: Yeah.

Illness 136

Illness Patient-Centered Screening Clinic 136

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!) What should our listeners take away from this study in clinical practice? Welcome to the GeriPal Podcast, Amber.

Patient-Centered 111

Patient-Centered Patients IT Healthcare 111

GeriPal

MARCH 20, 2025

And is there a middle path to provide some degree of comfort while also hastening the end of life? 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. Thaddeus, welcome to the GeriPal Podcast.

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IT Patient-Centered Patients Medical 88