FDA Law

MARCH 7, 2024

Clissold — The trio of CDER, CBER, and CDRH released a new draft guidance titled “ Use of Data Monitoring Committees in Clinical Trials ” that revises the 2006 guidance “Establishment and Operation of Clinical Trial Data Monitoring Committees” and, when final, will replace the 2006 guidance.

Clinic 105

Clinic Provider IT Utilities 105

Physician's Weekly

JUNE 29, 2025

They enrolled individuals diagnosed with irNeuropathy or irMyositis, along with cancer control s (CCs) and healthy controls (HCs). Spearman’s correlation was used to examine the relationships between complement levels, severity, and clinical outcomes of immune-related neurologic adverse events (irAE-n).

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Utilities Individual Relationship Diagnose 52

Physician's Weekly

JUNE 22, 2025

IL-6 blockades with tocilizumab did not improve short-term survival in advanced pancreatic cancer but showed potential anticachexia benefits and improved 18-month survival despite increased toxicity. The Randomized Phase II study was published in the May 2025 issue of the Journal of Clinical Oncology. The median follow-up was 8.1

Individual 52

Individual Clinic 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. Contact us today!

Healthcare Professional 52

Healthcare Professional Healthcare Community Medical Advice 52

FDA Law

FEBRUARY 9, 2024

Baumhardt, Senior Medical Device Regulation Expert — As an end of the year gift, FDA finalized its guidance document, Digital Health Technologies for Remote Data Acquisition in Clinical Investigations , in late December. The guidance addresses the use of DHTs in clinical investigations of drugs, biologics, and medical devices.

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Clinic Manufacturing Provider Electronics 105

FDA Law

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Cato — On May 2nd, FDA released a new draft guidance with recommendations for decentralized clinical trials (DCTs) for drugs, biologics, and devices.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.

Clinic 59

Clinic Telehealth Provider Electronics 59

BMJ

DECEMBER 16, 2021

We focus on five key areas and steps: 1) Deciding on the length of data collection, and timing and number of interviews; for example, researchers may consider whether the data collection points should be around researcher-led or participant-led key ‘events’ or at pre-established intervals. following individual or groups of participants).

Family Medicine 40

Family Medicine DO Families Family 40

The Motivated MD

OCTOBER 10, 2024

So, with this chapter, I hope to briefly touch on the basics of market investing and describe why simple diversification and index fund investing are the most effective ways for busy clinical physicians and healthcare providers to invest with the expectation of long-term gains. Most clinical physicians are busy. We simply cannot.

Finance 52

Finance Individual Management IT 52

Physician's Weekly

JUNE 11, 2025

Chae : The four pillars of obesity care is a helpful framework that defines the essential elements of obesity care, which include nutrition therapy, physical activity, behavioral modification, and, if clinically indicated, medical interventions (eg, medication management, bariatric procedures, and complication management).

Management 52

Management Primary Care Physicals Telehealth 52

FDA Law

DECEMBER 7, 2022

In simple terms from a non-scientist, these gene therapies add functional versions of genes to patients that do not have them, and thus the idea is to have these genes function in the same way as they do in individuals without these disorders.

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Clinic Patients IT Provider 119

Aspiring Minority Doctor

APRIL 18, 2021

In the event you are unsuccessful at extending your graduation date or securing an internship position, options for practicing medicine tend to become severely limited. Plus, I am constantly learning new things and staying up to date on clinical guidelines. This would require relocating and I am not aware of how much it pays.

GP 52

GP Medical Student Insurance General Practitioner 52

FDA Law

MARCH 8, 2023

eMDR submissions can be submitted in one of two ways: Health Level 7 Individual Case Safety Reports (HL7 ICSR) via AS2 (for high volume reporting) or by using FDA’s eSubmitter software (for low volume reporting). The eMDR requirements pertain to initial and supplemental MDRs and follow-up reports.

Electronics 59

Electronics Manufacturing Provider Medical 59

GeriPal

DECEMBER 2, 2022

So on today’s podcast we invite four brilliant individuals to talk about their perspective on how to change how we as a society and health care system partner with individuals with dementia. We’re going to be talking about things like creative engagement in individuals with dementia. Susan: Yeah, that was me.

Community 101

Community IT Individual Patient-Centered 101

FDA Law

NOVEMBER 1, 2023

Regulating LDTs: A Long and Winding Road In what might sound to some like protesting too much, the PR invokes FDA’s longstanding assertion that IVDs “manufactured” by laboratories are medical devices and that clinical laboratories that develop tests are acting as manufacturers. FDA’s position is, however, only one side of the story.

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Manufacturing Hospital Healthcare Medical 81

FDA Law

AUGUST 4, 2022

The approval process, pre-approval concerns, product labeling, clinical trials, adverse events reports, patent concerns, and exclusivity – these are all critical aspects in the commercialization process for drugs and biologics that are governed by the FDA.

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Government Clinic Individual Provider 40

FDA Law

APRIL 23, 2023

Notably, the Draft Guidance states that it is not intended to address other types of external controls, such as using summary-level estimates instead of patient-level data, nor does it discuss the use of external control data to supplement a control arm in a traditional randomized controlled clinical trial.

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Patient-Centered Clinic Patients Provider 49

GeriPal

MAY 5, 2022

Was there any mention about the impact that hearing loss has in communication or what we should do about it in clinical practice? We talk with Nick and Meg about: Why hearing loss is important not just in geriatrics but also for those caring for seriously ill individuals. I’m guessing not. How to screen for hearing loss. Transcript.

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IT Screening Hospital Clinic 102

GeriPal

OCTOBER 13, 2022

We have a discussion about the decision to remove race, a social construct, from clinical risk calculators (though I’m not 100% sold that race should always be removed – if removal is likely to worsen disparities for example – at least until a superior race-blind calculator can be developed). difficile infections.

Complication 97

Complication Patient-Centered IT Patients 97

GeriPal

MAY 19, 2022

It depends on the clinical situation. But I think people would have an embolic event if you gave them a flipping range. But we still, regardless of how you do this calculation have to temper it with clinical judgment. Mary Lynn: I’m willing to bet that you temper that calculation with your clinical judgment though.

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IT Patients Individual Relationship 139

FDA Law

MAY 8, 2023

In addition, manufacturers should identify whether the modifications will apply to all devices in the field (referred to as global adaptations) or will be implemented based on a specific clinical site or individual patients” (referred to as local adaptations).

Manufacturing 98

Manufacturing Provider Medical IT 98

ABIM

APRIL 24, 2025

Johnson, MD, FACP, FIDSA , Senior Vice President for Academic Affairs, added that ABIM provides program directors with aggregate performance data in their programs and, with permission, individual graduate data so that program directors can make adjustments to the programs as needed.

Board-Certified 40

Board-Certified Board-Certified Physicians Community Government 40

Permanente Medicine

MAY 20, 2025

When I started over 20 years ago, saw babies being born, used to do circumcisions in clinics, and then taking care of patients as they got more mature in their life, so to speak, and really loved that. I’m a family physician by training. Couldn’t imagine doing anything else.

Patient-Centered 52

Patient-Centered Patients Medical IT 52

Pamela Wible MD

JUNE 20, 2025

During that time, psychologist Herbert Freudenberger volunteered at a New York City free clinic treating addiction. He overheard the term and used it to describe himself and clinic staff in a 1974 article on staff burnout detailing long-term physical and psychological job stress. Let’s not waver on the truth.

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Medical Student Diagnosis Physicals Medical 246

FDA Law

MAY 17, 2022

It’s the quinquennial event when many of the UFAs are up for reauthorization. Without a fix, drug companies are incentivized to seek the broadest orphan drug designation as possible and then focus clinical studies only on the narrowest patient populations that would support approval.

IT 40

IT Patients Provider Individual 40

Annals of Family Medicine

NOVEMBER 20, 2024

Biological age was calculated using the KDM-BA and PhenoAge algorithms using a clinical index. Participants The study included 415,147 individuals with an average age of 56.5 The Cox proportional hazards model was used to examine the risk of adverse events associated with accelerated aging (biological age > chronological age).

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Screening Individual Relationship Diabetes 130

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. Now, in the pediatric emergency department, the diagnosis of reflux is primarily clinical. This measures both acid and non acid reflux events.

Diagnosis 52

Diagnosis Management IT Patient-Centered 52

Physician's Weekly

JUNE 22, 2025

Registry-based prediction models were applied to estimate individual prior probabilities. Assumptions were made regarding short-term disease progression and related hospital care in the absence of ICD implantation.

Hospital 52

Hospital Individual Clinic Patients 52

Physician's Weekly

JUNE 14, 2025

Model calibration was evaluated using the Brier score. The results showed that data were analyzed from 16,671 individuals in MIMIC-IV, 2,665 in SICdb, and 11,447 in eICU-CRD and ORAKLE demonstrated stronger predictive accuracy for MAKE30 compared to the XGBoost and Cox models. Its performance was compared to Cox and XGBoost models.

Patient-Centered 52

Patient-Centered Patients Individual Clinic 52

Physician's Weekly

JUNE 29, 2025

Baseline CSF α-synuclein SAA and clinical data were collected between Jan 1, 2005, and Nov 1, 2023. In the PPMI cohort, 73% [n=593 of 810] of SAA-positive individuals with Parkinson’s disease experienced an unfavorable outcome over a median 4.5-year 3.46), P =0.001] and Tübingen [n=135, HR 2.17 (1.07–4.41),

Individual 52

Individual Utilities Clinic 52

Annals of Family Medicine

NOVEMBER 20, 2024

Using linked administrative databases, we identified all instances of PIP-AP according to the STOPP-START criteria, which have previously been shown to predict adverse clinical events such as ED visits and hospitalizations. Residents were followed for 1 year or to date of death, whichever occurred first.

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Patients Provider Individual Hospital 130

Today's Hospitalist

JUNE 7, 2025

They presented a rapid clinical update Webinar in May 2025 hosted by the Society of Hospital Medicine. ” All anti-obesity medications, even the earlier generation of these drugs—which include orlistat, phentermine, phentermine/topiramate (Qsymia) and naltrexone/bupropion (Contrave)—cause clinically significant weight loss.

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Hospital Management Diabetes Patients 63

The Clinical Problem Solvers

DECEMBER 20, 2021

Highlight how structural racism against Asian-Americans surfaces in clinical settings, and describe means of counteracting such structures. Creating spaces where these experiences can be shared by patients as well as by practitioners can highlight the structural nature of seemingly individualized problems.

Community 52

Community Patient-Centered Relationship Healthcare 52

FDA Law

JULY 7, 2024

The guidance restates the central premise of the final rule, i.e., that LDTs are medical devices and the clinical laboratories that design, manufacture and use them to test patient specimens are manufacturers. 803), Reporting of Corrections and Removals (21 C.F.R. § 806) and Complaint Files (21 C.F.R. 820.198). .

Manufacturing 64

Manufacturing Provider Physicals Electronics 64

FDA Law

MARCH 17, 2022

Proposed 2022 CDC Clinical Practice Guideline for Prescribing Opioids, 87 Fed. et al, CDC Clinical Practice Guideline for Prescribing Opioids-United States, 2022, CDC. CDC Clinical Practice Guideline, 10. (We blogged on the final 2016 guideline here on March 17, 2016). 7,838 (Feb. 10, 2022); Dowell, Deborah, MD.,

Patient-Centered 75

Patient-Centered Clinical Practice Patients Management 75

GeriPal

FEBRUARY 20, 2025

We also explored several questions with them, including how to define trauma, its prevalence in older adults, the impact of past traumatic experiences, the potential triggers of trauma screening, and the application of trauma-informed principles in clinical practice. So there’s an event or a series of events.

IT 66

IT Patient-Centered Screening Patients 66

GeriPal

MARCH 9, 2023

FDA is considering approval, shifting away from Schedule I restrictions, paving the way for use in clinical practice. Psilocybin, the most commonly used psychedelic, increases heart rate and blood pressure, which may potentially lead to cardiovascular events. If you put on your clinical hats, what is demoralization to you?

Patient-Centered 91

Patient-Centered Community IT Medical 91

GeriPal

MAY 25, 2023

LJ: I’ll take that one that I feel really strongly that we are not assessing the right outcomes in advance care planning, and I think that’s part of the problem, is that we I think we do this in a lot of science and a lot of research in clinical medicine too. Hillary: So those all differ. Hillary: Absolutely true.

Community 95

Community IT Patient-Centered Primary Care 95