Annals of Family Medicine

NOVEMBER 20, 2024

Instrument/Dataset: Ten item subset within the 2023 Council of Academic Family Medicine’s (CAFM) Educational Research Alliance (CERA) survey, administered from Nov.20-Dec.22, members of one of the four CAFM organizations, selecting only active medical clinicians. Study Design and Analysis: Cross-sectional survey.

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Healthcare DO Family Medicine Healthcare Professional 130

Annals of Family Medicine

NOVEMBER 20, 2024

The American Academy of Family Physicians sought to reduce burnout and promote wellbeing among medical students and residents through program offerings, known as Physician Health First: Building Resiliency Intersectionally During Graduate Education (BRIDGE). Intervention: 4 series: Fall 2022; Spring 2023; Fall 2023; Spring 2024.

DO 130

DO Family Medicine Family Families 130

Annals of Family Medicine

NOVEMBER 20, 2024

A small-scale, peer navigation focused micro-elimination project was launched to facilitate treatment engagement and re-testing for individuals experiencing elevated risk of HCV re-infection. Micro-elimination projects aim to selectively foster diagnosis, treatment and reinfection of high priority demographic groups.

Behavioral Health Services 130

Behavioral Health Services Primary Care Patients Healthcare 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

FDA Law Blog

DECEMBER 4, 2023

11, 2023 ( DOJ Press Release ). 6, 2023 ( DOJ Press Release ). Pharmacists’ Corresponding Responsibility A controlled substance prescription, to be valid, must be issued for “a legitimate medical purpose by an individual practitioner acting in the usual course of [their] professional practice.” 1306.06.”

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Treatment Plan ER Government Patient-Centered 139

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

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).

Screening 130

Screening Clinic Individual Provider 130

OCFM

SEPTEMBER 20, 2023

Notice of Privacy Policy

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DO Family Medicine Primary Care Patient-Centered 52

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. If people in these groups don’t sign up for Medicare when they become eligible, they can find themselves responsible for all their medical bills for years.

Insurance 52

Insurance Patient-Centered Government Provider 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

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.

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Lab Testing Medical Patients Mental Health 52

Common Sense Family Doctor

DECEMBER 27, 2024

In 2023, a decade after the Affordable Care Act expanded Medicaid and began offering subsidized private insurance options in national and state-run marketplaces, the share of the population with health insurance reached 92.5% - the highest ever. Nevertheless, the U.S. is at the threshold of a once-in-a-lifetime opportunity.

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Primary Care Insurance Patient-Centered Medical Student 52

FDA Law Blog

JULY 31, 2023

Now, in July 2023, DEA has finally issued its final rule amending its regulations for partial filling of prescriptions for schedule II substances. 46,983 (July 21, 2023). 21 U.S.C. § Partial Filling of Prescriptions for Schedule II Controlled Substances, 85 Fed. 78,282 (Dec. The Final Rule a.

Electronics 98

Electronics Consulting Patients Medical 98

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.

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Patient-Centered Manufacturing Clinic Provider 52

Medical Xpress

APRIL 19, 2023

The study does not prove that living in disadvantaged neighborhoods causes memory and mental health problems for these individuals. It only shows an association.

Mental Health 73

Mental Health Education Individual IT 73

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

Medical Xpress

APRIL 18, 2023

Among individuals who consented to whole-exome sequencing and were identified as carriers of predisposition genes for hereditary breast and ovarian cancer (HBOC) or Lynch syndrome, 39.2%

Screening 69

Screening Individual Clinic 69

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

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

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

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.

Individual 64

Individual Patients Provider Medical 64

FDA Law Blog

JULY 17, 2024

This individual will play a key role in overseeing the new integrated Hub model and helping to develop and implement its strategic agenda action plan. those reviewed by the CDER Division of Rare Diseases and Medical Genetics). 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

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.

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Electronics Manufacturing Provider Medical 59

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.

Clinic 52

Clinic Education Clinical Practice Patient-Centered 52

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 ”. 5429, the “ Medication Affordability and Patent Integrity Act.”

Manufacturing 105

Manufacturing Provider IT Healthcare 105

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

FEBRUARY 21, 2024

By Véronique Li, Senior Medical Device Regulation Expert & Ana Loloei & Allyson B. It is intended to reduce regulatory burdens on medical device manufacturers and importers by enhancing global harmonization in device regulation. The final rule emphasizes risk management activities and risk-based decision making.

Manufacturing 59

Manufacturing Management Medical IT 59

FDA Law Blog

JULY 25, 2023

The canary in the coal mine for nitrosamines was their 2018 appearance in blood pressure medications called sartans. And FDA has had numerous with meetings with individual stakeholders seeking a better understanding of their approach to nitrosamines. What is FDA doing about NDRSIs? Seek, and ye shall find, so FDA hopes.

IT 52

IT Manufacturing Individual Medical 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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Manufacturing Provider Medical IT 98

FDA Law Blog

APRIL 22, 2024

We blogged in February about the October 2023 letter from former DEA Administrators, Ms. Democratic senators also weighed in, supporting rescheduling to schedule III in December 2023. The Single Convention imposes more stringent controls on schedule IV substances than on schedule I substances. 811(d) and U.S.

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Manufacturing Consulting IT Individual 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. §

Government 59

Government Medical IT Manufacturing 59

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 ). through August 30, 2023.

Manufacturing 59

Manufacturing Clinic IT Transportation 59

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

MAY 4, 2023

Section 3606(a) of the Food and Drug Omnibus Reform Act (FDORA) directed FDA to “issue or revise draft guidance that includes recommendations to clarify and advance the use of decentralized clinical studies to support the development of drugs and devices,” not later than December 29, 2023. DHTs include monitoring instruments (e.g.,

Clinic 59

Clinic Telehealth Provider Electronics 59

FDA Law Blog

AUGUST 17, 2023

Tobolowsky — In January 2023, Vanda Pharmaceuticals, Inc. FDA-2023-P-0313 and FDA-2023-P-0344 ) regarding its product Hetlioz (tasimelteon). Vanda) submitted two interesting and substantially similar citizen petitions (Docket Nos. 355(j)(2)(A)(v).

Manufacturing 40

Manufacturing IT Medical Individual 40

FDA Law Blog

FEBRUARY 23, 2025

Such assessments are highly individualized and difficult to map onto the few examples provided by FDA in its guidance. For example, in an October 13, 2023 WL to ReNovo, Inc., Manufacturers should, therefore, welcome any additional source of examples of device changes to aid in evaluating their own.

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Manufacturing Provider Consulting IT 64

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 C.F.R. §§ 1306.04(a),

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Insurance Patients Utilities Chronic Condition 52