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

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. 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).

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Electronics Consulting Patients Medical 98

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. We all want to know how to stop fearing the future.

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Primary Care Doctor Primary Care Board-Certified Physicals 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.

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Mental Health Education Individual IT 73

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

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.

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IT Manufacturing Individual Medical 52

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).

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Patient-Centered Community Medical Specialty Clinic 105

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! For those who don’t know, this is one of my favorite designers.

IT 52

IT Medical Mental Health Patients 52

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

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. By Larry K. Houck Last month the U.S. 81, 86, 251.

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Individual Patients Provider Medical 64

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.,

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Medical Patients Healthcare Electronics 45

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 Management 40

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. Nwamaka Eneanya and Jennifer Tsai to discuss the limitations and harms of race-based medicine in clinical practice.

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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 ”. Koblitz & Kurt R. But it is not always clear which types of patents are eligible for listing in the Orange Book. Avdel amicus brief).

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Manufacturing Provider IT Healthcare 105

FDA Law Blog

OCTOBER 2, 2023

In contrast, the new September 2023 Confirmatory Evidence Guidance is dedicated solely to the single study plus confirmatory evidence pathway. Use of this single study authority has been crucial to breakthroughs in drug development for rare and serious conditions including those with unmet medical needs.

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IT Clinic Provider Medical 64

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. See 21 CFR 807.81(a)(3)

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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.

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.

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Manufacturing Management Medical IT 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

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. 811(d) required classification of marijuana as a schedule I or II substance to comply with U.S. 811(d) and U.S. 811(d) and U.S.

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Manufacturing Consulting IT Individual 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 ). By McKenzie E. Cato & Jeffrey N. Gibbs & Allyson B. lay users). seeking treatment).

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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.

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Patient-Centered Medical Patients IT 59

GeriPal

NOVEMBER 9, 2023

Hot off the presses RCT in JAMA October 2023: Study that looks at 1000 female resident physicians at 26 sites that showed that coaching improved each outcome assessed (burnout, moral injury, imposter syndrome, self-compassion, and flourishing). [link] 2. Summary Transcript Summary Coaching is in. We address: What is coaching? AlexSmithMD 1.

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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., The guidance includes examples of changes and flowcharts that frequently make their way into formal company procedures. But this guidance has its limitations.

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Manufacturing Provider Consulting IT 64

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).

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Manufacturing IT Medical Individual 40

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

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.” It finalized a draft guidance published in 2022.

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Provider Screening IT Government 59

FDA Law Blog

JULY 4, 2023

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. FDA will determine the total number of individuals who can attend the consolidated proceedings in person. 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. By Larry K. 823(g)(1).

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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. Serial testing was defined as testing symptomatic individuals twice over three days with at least 48 hours between tests, which is in accordance with study findings from the National Institute of Health referenced here and current EUA labeling for serial testing.

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Specialization Clinic Provider IT 40

Physician's Weekly

JUNE 22, 2025

High social risk burden in adults with IBD drives emergency care use and medication gaps—spotlighting the urgent need for social screening in clinical practice. 10.2]) and cost-related medication non-adherence (OR, 11.8 [2.7-52.1]),

Healthcare 52

Healthcare Transportation IT Insurance 52

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

Today's Hospitalist

JUNE 7, 2025

Because many medications can cause weight gain, doctors should consider more weight-neutral alternatives. Medical societies and hospitals are weighing in on periprocedural concerns in patients taking GLP-1s who need procedures or surgeries. These medications are truly life-changing for many patients.” Nor should they be.

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Hospital Management Diabetes Patients 66

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.

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Community Education Patient-Centered Relationship 52

Medical Xpress

JUNE 16, 2025

The goal is to support clinical trials and bring in another $50 million in private investment to help ibogaine win approval from the U.S. Food and Drug Administration (FDA). The process could take years. Ibogaine is made from the root of a plant found in Africa. It has been banned in the U.S. Former Texas Gov.

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Mental Health IT Specialization Medical 52