The Medical Futurist

JUNE 19, 2025

Determining patients’ prognosis Due to individual variations in genetics and lifestyle choices, each person ages at a different rate. However, this visual assessment can be impaired by individual biases, thereby impacting objective care decisions. FaceHeart also received FDA approval for the heart rate component in 2023.

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The Clinical Problem Solvers

JUNE 26, 2023

[link] CPSolvers: Anti-Racism in Medicine Series Episode 22 – Live from SGIM 2023: Best of Antiracism Research at the Society of General Internal Medicine’s 2023 Annual Meeting Show Notes by Alec J. Following residency, she was a Robert Wood Johnson Clinical Scholar and received health services research methodology training.

Electronics 52

Electronics Internal Medicine Patient-Centered Healthcare 52

Annals of Family Medicine

NOVEMBER 20, 2024

Populations Studied: Primary care providers who delivered care to young children and parents/caregivers of children who were under the age of six during the pandemic. Instrument: An online survey was distributed, and subsequent semi-structured telephone or video interviews were conducted between May and December 2023.

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Physician's Weekly

JUNE 13, 2025

An expert panel unveiled a preoperative cannabis use assessment tool to aid in planning informed, individualized anesthesia and analgesia patient care. An expert panel has created a preoperative cannabis use assessment tool to aid healthcare professionals in planning informed, individualized anesthesia and analgesia care for patients.

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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, Study Design and Analysis: Cross-sectional survey. POPULATION STUDIED: U.S. All p’s < 001.

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Annals of Family Medicine

NOVEMBER 20, 2024

Context Healthcare providers often struggle to treat patients with chronic pain. Dataset: We used data routinely collected through the CPSMP between December 2017 and May 2023. Population studied: The CPSMP targeted individuals suffering from chronic pain in the Champlain region of Eastern Ontario.

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Annals of Family Medicine

NOVEMBER 20, 2024

Context: Traditional clinical health datasets often fail to represent the diversity and breadth of real-world disease, influencing research and AI tools developed on those datasets. Study Design and Analysis: We employed Google Search ads to gather dermatology images from the public, with informed consent, between March and November 2023.

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Annals of Family Medicine

NOVEMBER 20, 2024

Objective: To examine the impact of discontinuation of statins compared to continuation on clinical outcomes. We searched MEDLINE, Embase, Cochrane Central Registry of Trials (inception to August 2023). Our findings underscore the need for RCT evidence in appropriately selected individuals, to guide clinical decision-making.

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The Clinical Problem Solvers

DECEMBER 16, 2020

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

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Clinic Education Clinical Practice Patient-Centered 52

My Green Doctor

APRIL 4, 2025

According to the 2023 report of the Lancet Countdown, mortality caused by extreme heat events increased by 53.7% It tells your office colleagues and patients that your healthcare practice or clinic is committed to forging a healthier work space and community. from 2000 to 2018 among people over 65 years old. Let’s talk!

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FDA Law Blog

MAY 4, 2023

Cato — On May 2nd, FDA released a new draft guidance with recommendations for decentralized clinical trials (DCTs) for drugs, biologics, and devices. In a DCT, trial-related activities may occur in trial participants’ homes, at local health care providers’ offices, or in local clinical laboratories.

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The Clinical Problem Solvers

APRIL 3, 2023

[link] CPSolvers: Anti-Racism in Medicine Series Episode 20 – Medical Racism and Indigenous Peoples Show Notes by Sudarshan (“Sud”) Krishnamurthy April 4, 2023 Summary: This episode highlights the checkered past of medicine and the advancements in the field that have occurred at the expense of the humanity of Indigenous peoples.

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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

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. clinical pharmacology/biomarkers, animal models, real-world evidence and other externally controlled comparisons [e.g.,

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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.

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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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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. Test deployment for the changes listed above were deployed to eMDR on August 19, 2022 and will be deployed to production on March 17, 2023.

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Electronics Manufacturing Provider Medical 59

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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FDA Law Blog

MAY 8, 2023

FDA recommends that PCCPs specify only a “limited number” of modifications but does not provide a limit on the number of modifications that can be included. If the proposed performance evaluation methods are different from the original methods used, the manufacturer should describe the differences and provide a justification for the changes.

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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 ). lay users). seeking treatment). seeking treatment).

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Manufacturing Clinic IT Transportation 59

PEMBlog

MAY 1, 2025

In this episode, we tackle the clinical mischief of Parvovirus B19 , a common viral infection with a surprisingly wide range of manifestationsfrom the classic slapped cheek rash of erythema infectiosum to aplastic crises in children with hemolytic anemias and fetal hydrops in pregnant contacts. link] Edwards, Morven S. UpToDate , Jun.

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Complication Patient-Centered Patients Clinic 83

FDA Law Blog

OCTOBER 2, 2023

The eagerly anticipated guidance, Demonstrating Substantial Evidence of Effectiveness With One Adequate and Well-Controlled Clinical Investigation and Confirmatory Evidence (i.e., Instead, FDA’s determination of whether a single study plus confirmatory evidence could provide substantial evidence is to be “based on relevant science.”

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PEMBlog

SEPTEMBER 6, 2023

They carry existing diagnoses and are followed by outpatient mental health providers. Attention to any toxidromes, any abnormal vital signs or mental status, eye findings, and neurologic examination provide the greatest help in narrowing the differential diagnosis. Hosp Pediatr (2023) 13 (1): 66–71 2015;34(5):812-818 Chun TH.

Lab Testing 52

Lab Testing Medical Patients Mental Health 52

FDA Law Blog

APRIL 23, 2023

This Draft Guidance focuses on the use of patient-level data from other clinical trials or from RWD sources. 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.

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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.

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Provider Screening IT Government 59

PEMBlog

OCTOBER 18, 2024

The condition affects multiple organ systems—muscular, cardiac, and respiratory—leading to a myriad of clinical complications. Emergency Care Plans and Advanced Directives Many DMD patients will arrive with comprehensive emergency care plans or letters from their providers. Updated 2023 Jul 10]. Pediatrics. doi: 10.1542/peds.2018-0333I.

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Patients Complication Management Consulting 52

FDA Law Blog

MAY 19, 2023

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., analytical, clinical and stability).

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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.

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Insurance Patients Utilities Chronic Condition 52

The Clinical Problem Solvers

MARCH 4, 2024

42:00 Abolitionist reimaginings of Health 55:05 Democratizing Narrative Medicine 1:03:05 Closing Remarks and Clinical Pearls Speaker biographies (Abbreviated) Zahra Khan is an educator and editor whose work emerges at the intersection of narrative, healing and disability justice, and liberation pedagogy. Stories are not inherently just.

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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. Other states like Oregon and Colorado have already launched legal clinics using psilocybin, the compound found in mushrooms, The Times reported. The content is provided for information purposes only.

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Mental Health IT Medical Specialization 52

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.” By James E. Valentine & Charles D.

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Clinic Supply Chain Clinical Practice Patient-Centered 64

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 110

Doctor On Demand

APRIL 28, 2025

Urgent care clinics provide quick diagnoses and treatments, including antibiotics if needed. In fact, most sore throat symptoms resolve in three days for 60-70% of patients, according to March 2025 UpToDate, an evidence-based clinical decision support system used by healthcare professionals. This requires emergency treatment.

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GeriPal

JANUARY 16, 2025

These individuals may become unrepresented, meaning they lack the capacity to make a specific medical decision, do not have an advance directive for that decision, and do not have a surrogate to help. How should we care for unrepresented individuals in inpatient and outpatient settings? Why not use the older term unbefriended?

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Patient-Centered IT Patients Healthcare 109

FDA Law Blog

JULY 9, 2024

Livornese — The Food and Drug Omnibus Reform Act (“FDORA”), enacted in December 2022, added a requirement that sponsors submit Diversity Action Plans (“DAPs”) for certain clinical studies involving drugs, biological products, or devices (codified at 21 U.S.C. § 355(z)(3) and 21 U.S.C. 360j(g)(9)(A)). intended use population.

Clinic 59

Clinic Provider Individual IT 59

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. Alex: And we’re delighted to welcome Todd Semla, who is a clinical pharmacist and associate professor at the Feinberg School of Medicine at Northwestern University.

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Medical IT Patients Clinic 97

FDA Law Blog

OCTOBER 17, 2023

Non-Addictive Medical Products to Treat Pain or Addiction The SUPPORT Act ( Public Law 115-271 ) mandated that FDA issue a guidance document to provide information on how the Agency can apply section 515B of the FD&C Act to non-addictive medical products intended to treat pain or addiction. By Philip Won & Lisa M.

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