Annals of Family Medicine

NOVEMBER 20, 2024

to complete an analysis of qualitative data collected from primary care clinician and staff perspectives on the use of anti-obesity medications. Setting or Data Set: Baseline and follow-up semi-structured interviews conducted with clinicians and staff between February 2021 and August 2023 (N=220).

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Primary Care Electronics Provider Management 130

Annals of Family Medicine

NOVEMBER 20, 2024

Objective: To develop a scalable, representative dermatology dataset using crowdsourcing via internet search ads, enhancing medical education and AI application development. Study Design and Analysis: We employed Google Search ads to gather dermatology images from the public, with informed consent, between March and November 2023.

Education 130

Education Community Individual Clinic 130

Physician's Weekly

JUNE 19, 2025

When Alyne Diamond fell off a horse in August 2023 and broke her back, her employer-based health plan through UnitedHealthcare covered her emergency care in Aspen, Colorado. The insurer not only stopped paying current claims but also moved to claw back tens of thousands of dollars it had paid to providers in the two years since she turned 65.

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Insurance Patient-Centered Government Provider 52

FDA Law Blog

DECEMBER 4, 2023

Houck — Separate decisions by federal district courts in Texas and Puerto Rico in the past two months provide cautionary tales for every pharmacy and wholesale distributor dispensing or distributing controlled substances. 11, 2023 ( DOJ Press Release ). 6, 2023 ( DOJ Press Release ). By Larry K. Zarzamora Press Release.

Treatment Plan 139

Treatment Plan ER Government Patient-Centered 139

Annals of Family Medicine

NOVEMBER 20, 2024

We searched MEDLINE, Embase, Cochrane Central Registry of Trials (inception to August 2023). Population Studied: Adults ≥18 years Intervention/Instrument: Discontinuation of statin medications Outcome Measures: All-cause mortality, cardiovascular (CV) mortality, and CV events (e.g., Quality assessment (RoB 2.0 stroke and MI).

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Screening Clinic Individual Provider 130

OCFM

SEPTEMBER 20, 2023

Notice of Privacy Policy

Family Medicine 52

Family Medicine DO Primary Care Patient-Centered 52

My Green Doctor

APRIL 4, 2025

Todd Sack concludes that, “ the medical office waiting room appears to be an accepted, time-efficient, and effective site to communicate knowledge on climate change and health. ” According to the 2023 report of the Lancet Countdown, mortality caused by extreme heat events increased by 53.7% The healthcare sector contributes 8.5%

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Healthcare Professional Healthcare Community Medical Advice 52

Common Sense Family Doctor

DECEMBER 27, 2024

" The Gilded Age of Medicine is Here ," announced the title of a recent New Yorker article about the tactics of private equity firms that provide infusions of cash to struggling hospitals in order to extract hundreds of millions of dollars in profits by slashing costs to the bone and endangering the health of patients. Nevertheless, the U.S.

Primary Care 52

Primary Care Insurance Patient-Centered Medical Student 52

PEMBlog

SEPTEMBER 6, 2023

When should the emergency physician obtain lab tests to medically clear such patients? Also, while evidence for lab evaluation based on history and exam findings was established for adults, children were considered to have a medical etiology (organic psychosis) until proven otherwise. Acute onset psychosis is relatively rare.

Lab Testing 52

Lab Testing Medical Patients Mental Health 52

FDA Law Blog

JUNE 21, 2023

Cato — On June 1, CDRH announced that it is seeking public comment on questions regarding how CDRH can facilitate access to medical technologies designed for use outside of traditional clinical settings, particularly in the home. At-home medical technologies include, but are not limited to, monitoring and wearable devices (e.g.,

Medical 45

Medical Patients Healthcare Electronics 45

FDA Law Blog

SEPTEMBER 20, 2021

When FDA published the fiscal years (FY) 2023-2027 goals letter at the end of August, making known their commitments and planned initiatives for the coming years, we were both excited by many of the announcements, while recognizing the real success will come from how the Agency implements them.

Patient-Centered 52

Patient-Centered Manufacturing Clinic Provider 52

Priority Physicians

JANUARY 27, 2025

Many of us know where our meals come from, have sufficient clothing, enjoy roofs over our heads, access heating and air conditioning, use reliable transportation, and receive effective medications. of adults in the state showed significant symptoms of anxiety or depression in 2023. So why is the general population so anxious?

Primary Care Doctor 52

Primary Care Doctor Primary Care Board-Certified Physicals 52

FDA Law Blog

JULY 17, 2024

Importantly, the Hub is intended to establish a new model within FDA, which leverages cross-Agency expertise in providing guidance and conducting reviews for products for rare disease populations. those reviewed by the CDER Division of Rare Diseases and Medical Genetics).

Patient-Centered 105

Patient-Centered Community Medical Specialty Clinic 105

FDA Law Blog

NOVEMBER 6, 2023

is pleased to announce it took top honors in two categories in the 2023 LMG Life Sciences Awards, which recognize the best life science practitioners and firms over the past 12 months from the United States, Canada, and Europe. They range from individuals and start-up companies with no in-house legal staff to large multinational corporations.

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Government Provider Medical Individual 40

FDA Law Blog

MAY 19, 2025

For a controlled substance prescription to be effective, that is valid, it must be issued for a legitimate medical purpose by an individual practitioner acting in the usual course of their professional practice. 81, 86, 251. 81, 89, 251.

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Individual Patients Provider Medical 64

FDA Law Blog

SEPTEMBER 19, 2023

That Policy Statement , issued on September 14, 2023, warns companies that improper listing of patents in the Orange Book could be “ an unfair method of competition in violation of the FTC Act ”. And FDA did not provide a substantive response to 5 Requests for Advisory Opinions seeking clarification of the issue.

Manufacturing 105

Manufacturing Provider IT Healthcare 105

FDA Law Blog

MARCH 8, 2023

By Véronique Li, Senior Medical Device Regulation Expert — On March 17, 2023, enhancements to FDA’s electronic Medical Device Reporting (eMDR) system will go live. Since the final rule took effect on August 14, 2015, medical device manufacturers and importers have been required to submit MDRs in an electronic format.

Electronics 59

Electronics Manufacturing Provider Medical 59

Aspiring Minority Doctor

FEBRUARY 7, 2023

My original flight was changed by the airline a couple of months prior, so I specifically added the Atlanta layover so that I could have lunch with one of my dearest friends from medical school, but she absolutely surprised me with the best birthday gift ever! Rox (@drashleyroxanne) But back to the trip. It was such a beautiful gift.

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IT Medical Mental Health Patients 52

FDA Law Blog

MAY 8, 2023

Baumhardt, Senior Medical Device Regulation Expert & Philip Won & Gail H. In February 2020, FDA granted a de novo classification request (DEN190040) for software intended to assist medical professionals in the acquisition of cardiac ultrasound images and that included a PCCP for future software modifications.

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The Clinical Problem Solvers

DECEMBER 16, 2020

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. These factors include a high-protein diet, muscle mass, creatinine generation, and certain medications.

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Clinic Education Clinical Practice Patient-Centered 52

FDA Law Blog

MAY 4, 2023

In a DCT, trial-related activities may occur in trial participants’ homes, at local health care providers’ offices, or in local clinical laboratories. With regard to clinical trial visits and activities, the draft guidance provides examples of the types of approaches that may be possible with a DCT.

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Clinic Telehealth Provider Electronics 59

FDA Law Blog

FEBRUARY 23, 2025

To help in evaluating device changes, manufacturers commonly refer to FDAs guidance Deciding When to Submit a 510(k) for a Change to an Existing Device, which provides FDAs interpretation of the changes it believes could significantly affect the safety or effectiveness of a device. For example, in an October 13, 2023 WL to ReNovo, Inc.,

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PEMBlog

APRIL 20, 2023

It is therefore no hyperbole to say that Emicizumab has been a life-changing therapy for individuals with hemophilia A who have factor VIII inhibitors (alloantibodies against factor VIII). Emicizumab allows these individuals to have good bleed control, improvement in their joint health and their quality of life. Epub 2023 Jan 16.

Individual 52

Individual Patient-Centered Patients IT 52

FDA Law Blog

JUNE 22, 2023

FDA hailed its authorization of the Lucira OTC home test for influenza and COVID-19 as “underscor[ing] the Agency’s continued commitment to increase availability of accurate and reliable at-home diagnostic tests” ( April 2023 FDA Update to CDC ). seeking treatment).

Manufacturing 59

Manufacturing Clinic IT Transportation 59

FDA Law Blog

AUGUST 8, 2024

Governors, state cannabis regulators, law enforcement groups and local governments weighed in, as did marijuana advocates and opponents, marijuana industry associations, Members of Congress, federal law enforcement groups, healthcare and human rights groups, unions and trade associations, and private individuals. 812(c)(c)(10). 21 U.S.C. §

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Government Medical IT Manufacturing 59

FDA Law Blog

OCTOBER 2, 2023

A brief explainer on confirmatory evidence: how we got here Before we dive into the specifics of the new guidance, we should explain that the statutory standard we allude to is the requirement that an applicant provide “substantial evidence of effectiveness” to obtain approval of an NDA or BLA.

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IT Clinic Provider Medical 64

FDA Law Blog

DECEMBER 13, 2023

Sasinowski — On December 12, 2023, FDA announced the creation of a new advisory committee specifically for treatments for genetic metabolic diseases, the Genetic Metabolic Diseases Advisory Committee, or “GeMDAC.” GeMDAC’s mandate is to advise the Agency on these complicated issues in this challenging area of medical product development.

Patient-Centered 59

Patient-Centered Medical Patients IT 59

FDA Law Blog

NOVEMBER 2, 2023

Lewis, Senior Regulatory Device & Biologics Expert — On October 20, 2023, FDA announced the availability of the final guidance authored by CBER titled “Voluntary Consensus Standards Recognition Program for Regenerative Medicine Therapies.” Tobolowsky & Richard A. It finalized a draft guidance published in 2022.

Provider 59

Provider Screening IT Government 59

FDA Law Blog

JULY 4, 2023

The CARES Act also provides for an administrative hearing process that may be utilized under certain conditions following the formal dispute resolution process. The draft Monograph FDR Guidance clarifies that FDR is appropriate only when there is a scientific and/or medical dispute related to a final order. By Deborah L.

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Utilities Provider Individual IT 52

FDA Law Blog

JUNE 27, 2024

After issuing an Order to Show Cause and Immediate Suspension of Registration in September 2022, and an administrative hearing in March 2023, DEA adopted the hearing Administrative Law Judge’s (“ALJ’s”) Recommended Decision to revoke Coconut Grove’s registration based on the public interest factors of 21 U.S.C. 21 U.S.C. § a), 1306.06.

Insurance 52

Insurance Patients Utilities Chronic Condition 52

FDA Law Blog

APRIL 23, 2023

The Draft Guidance recommends that, where possible, the outcome should be assessed by individuals blinded to treatment status, which may require re-adjudication of externally controlled data. Outcomes of interest are more likely to be recorded in clinical records when the events are objective and require immediate medical attention (e.g.,

Patient-Centered 49

Patient-Centered Clinic Patients Provider 49

FDA Law Blog

MAY 19, 2023

Baumhardt, Senior Medical Device Regulation Expert & Richard A. Final Release Criteria Special Controls Sponsors will need to provide the final manufacturing release criterion with evidence that lots released at the extremes of the specification will still meet the claimed device performance (i.e.,

Specialization 40

Specialization Clinic Provider IT 40

GeriPal

MAY 18, 2023

Summary Transcript Summary Hot off the press is a brand spanking new updated 2023 AGS Beers Criteria for Potentially Inappropriate Medication Use in Older Adults. The Beers Criteria is one of the most frequently cited reference tools in geriatrics, detailing potentially inappropriate medications to prescribe to older people.

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Medical IT Patients Clinic 97

The Clinical Problem Solvers

MARCH 4, 2024

Together, our guests offer context around how the medical and carceral systems are deeply intertwined and go hand-in-hand. Explain the significance of abolition medicine, and the role of the medical system in upholding and perpetuating carceral logics.

Community 52

Community Education Patient-Centered Relationship 52

Medical Xpress

JUNE 16, 2025

In a study published in Nature Communications , led by researchers at National Taiwan University (NTU) and National Tsing Hua University (NTHU), scientists used the deepest-ever two-photon calcium imaging in awake mice to directly observe how individual SCN neurons respond to light. The content is provided for information purposes only.

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Provider Medical Complication Diabetes 109

The Motivated MD

SEPTEMBER 19, 2024

For the better half of 2024, I have been periodically writing posts that are individual articles that double as potential chapters to a future book. Before we discuss each individual savings account, let us first highlight exactly what it means to ‘automate’ your savings. So yes, humans make mistakes.

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Finance Individual Education Healthcare Professional 52

Doctor On Demand

APRIL 28, 2025

Urgent care clinics provide quick diagnoses and treatments, including antibiotics if needed. These symptoms require immediate medical attention. Changes in voice (“hot potato” voice) Speaking in a muffled, strained voice, which some doctors call a “hot potato” voice, indicates severe swelling in the throat that needs medical attention.

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