Physician's Weekly

JUNE 22, 2025

Participants rated each outcome on a 9-point Likert scale to determine its importance. The results showed that out of 58 outcomes assessed in round 1, along with 3 additional outcomes, 27 were excluded, and 34 proceeded to a consensus meeting.

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FDA Law Blog

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Clissold — The trio of CDER, CBER, and CDRH released a new draft guidance titled “ Use of Data Monitoring Committees in Clinical Trials ” that revises the 2006 guidance “Establishment and Operation of Clinical Trial Data Monitoring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

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Physician's Weekly

JUNE 15, 2025

The following is a summary of “Clinical and imaging strategies for the assessment of the ocular side effects of systemic targeted anti-cancer therapies,” published in the April 2025 issue of the European Journal of Cancer by Michaels et al.

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Physician's Weekly

JUNE 11, 2025

Regarding safety, treatment-related adverse events occurred in 83.5% in the atezolizumab arm, with a greater proportion of patients experiencing grade 3 or 4 adverse events in the combination arm (25.6%) than the atezolizumab arm (5.8%). in the combination arm compared with 40.0% The researchers reported that 6.2%

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FDA Law Blog

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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FDA Law

JUNE 18, 2025

With the available information, a product undesignated voucher would seem to provide the most flexibility and allow companies to pivot from one program to another in the event of unforeseen circumstances, such as ambiguous clinical trial results or problems with a manufacturing facility.

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FDA Law Blog

JUNE 2, 2025

Just before this decisive event, though, FDA released a relatively rare Warning Letter to a manufacturer of research use only (RUO) reagents. RUO-labeled reagents and materials are often used in LDTs in clinical laboratories. Therefore, the events surrounding this particular Warning Letter preceded the LDT decision.

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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!

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Physician's Weekly

JUNE 25, 2025

I’m the Vice Chairman of Rheumatology at the Cleveland Clinic and the co-director of the Center for Vasculitis Care and Research. And I’m here today to talk about giant cell arteritis in clinical practice. Video Transcript: Hi, this is Dr. Len Calabrese. Hello everyone. I’m Paras Karmacharya. I am Dr. Adam Killian.

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FDA Law Blog

JANUARY 30, 2025

They also present a more intense focus on the timelines for confirmatory study initiation and completion as well as the feasibility of those studies to verify clinical benefit within those timelines. However, it left unanswered what underway means, noting an intention to address this authority in the now published January 2025 draft guidance.

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Physician's Weekly

JUNE 29, 2025

Spearman’s correlation was used to examine the relationships between complement levels, severity, and clinical outcomes of immune-related neurologic adverse events (irAE-n). Serum concentrations of 11 complement components were measured using multiplex enzyme-linked immunosorbent assays.

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Sound Physicians

NOVEMBER 19, 2024

It is, by design, built into the ways we educate, train, and support our clinical leadership. This event, which is offered nationally, brings a cohort of medical directors together for in-person training that reinforces the owner’s mentality we want each of our medical directors to have when leading their local p ractice.

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Physician's Weekly

JUNE 16, 2025

years after primary TAA to examine implant survivorship and clinical and radiographic outcomes. percent) had adverse events, with medial gutter debridement (22 ankles; 16.9 “Our clinical and robotic testing show outstanding wear properties of the components.” Jonathan Day, M.D., Three cases of cysts occurred (2.3

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FDA Law Blog

OCTOBER 18, 2023

Lenz, Principal Medical Device Regulation Expert — Although it seems not widely known outside of the medical device industry, FDA can require sponsors to include clinical data as part of a 510(k) submission. By Adrienne R. The Draft Guidance provides specific examples illustrating the application of each scenario.

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CDOCS

APRIL 27, 2021

<p><span style="font-size:14px">For the first time ever, CDOCS is gathering its entire community for three hours of engaging clinical education, live engagement with some of the best minds in dentistry and special access to incredible offers.& Sam Puri said. &ldquo;It&rsquo;s

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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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FDA Law Blog

DECEMBER 7, 2022

This was despite the 6-month data also demonstrating clinical benefits in reduction of bleeding events and declines in the use of FIX replacement therapy. It takes many years to determine if something provides durable treatment and to what degree it may fade over time.

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FDA Law Blog

SEPTEMBER 23, 2022

For example, Table 20 in Section 6 of the current Latuda labeling includes the term “somnolence” with the footnote “Somnolence includes adverse event terms: hypersomnia, hypersomnolence, sedation, and somnolence.” Typically, clinical trial subjects are questioned regarding adverse events, and investigators record them in their own words.

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FDA Law Blog

FEBRUARY 28, 2024

As the approval was granted using the accelerated approval pathway, the approval was subject to a postmarketing requirement to verify and describe the clinical benefit of the drug in a Phase 3 trial. Tobolowsky & Michelle L. All in all, the new expedited procedures took about 7 months from proposal to withdrawal.

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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).

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FDA Law Blog

JULY 24, 2023

This time, rather than use codes and patent certifications, the fight is over orphan drug exclusivity (“ODE”), with Jazz challenging FDA’s clinical superiority decision concerning sodium oxybate in the treatment of narcolepsy. 360cc(c), the statute does not permit FDA to promulgate regulations to use clinical superiority to break ODE.

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PEMBlog

OCTOBER 11, 2023

Clinical signs of bladder injury are nonspecific. However, if a patient exhibits hematuria (blood in the urine), suprapubic pain, abdominal pain, or experiences difficulty or inability to urinate after a traumatic event, evaluation for bladder injury must be conducted.

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Vida Family Medicine

AUGUST 26, 2024

From specialized obesity clinics to online services offering quick prescriptions, the options can feel overwhelming. You might start skipping social events to avoid "unhealthy" foods, skipping meals if your “safe” foods aren’t available, or over-exercising despite injury or illness. But how do you know what is safe and who to trust?

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Barton Associates

JUNE 19, 2025

In fact, hospitals, clinics, and other facilities are already reeling from a shortage of providers and it’s hurting patients— according to the United States Department of Health and Human Services (HHS) , tens of millions of Americans live in areas with shortages of primary care, dental, and mental health professionals.

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GeriPal

JANUARY 23, 2025

Join us as we dive deeper into these studies and discuss the implications for clinical practice and patient care. Summary Transcript CME Summary Its another deprescribing super special on today’s GeriPal Podcast, where we delve into the latest research on deprescribing medications prescribed to older adults. Alex 01:23 Yeah. Here we go.

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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.

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FDA Law Blog

FEBRUARY 27, 2025

The conference is billed as the premier event to provide folks with a roadmap to navigate the difficult terrain of FDA regulatory law. You can access the conference brochure and sign up for the event here. And it is exactly that! As such, we can offer our readers a special 10% discount. The discount code is: D10-999-FDA25.

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Aspiring Minority Doctor

OCTOBER 10, 2021

It's been a healthy mix of clinic and operating, and I'm enjoying seeing the diversity within the field of Urology. I'm never this cute when I'm at work lol I'm officially in month four of plastic surgery residency and just realized it's been a while since I've caught everyone up to speed. ProudMommy #BlackGirlMagic in the Operating Room!

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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).

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CDOCS

MARCH 15, 2021

Patients depend on our clinical knowledge as well as our recommendations and relationships with our specialist partners.</span></span></p> & We participate within our dental community in educational meetings and events, which builds our trust in the specialist. .</span></span></p>

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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.

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ABIM

JUNE 12, 2025

The questionnaire gathers information about clinical work and practice patterns, and ABIM uses the information to help update exam blueprints, develop policies for initial certification and MOC, and ensure adequately diverse representation of the profession in research. Community Practice in ABIM Governance* Erica N.

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Permanente Medicine

MAY 20, 2025

” Related AI scribes story: Analysis: AI scribes save physicians time, improve patient interactions and work satisfaction Dr. Nguyen also highlighted the potential to utilize artificial intelligence and Kaiser Permanente’s extensive medical database to develop predictive analytic models aimed at enhancing patient care.

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FDA Law Blog

JANUARY 18, 2022

FDA is seeking feedback on the challenges that a manufacturer of a 3D-printing system may face in being responsible for FDA regulatory requirements for devices that are 3D-printed by independent healthcare facilities, including with respect to adverse event reporting. This guidance document is still in effect today.

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FDA Law Blog

JANUARY 12, 2025

Background on Accelerated Approval The key concept, an ingenuity of FDA itself that has been around since the beginning of accelerated approval, is to allow earlier access to a promising therapy for a serious condition with an unmet medical need based on an endpoint that is reasonably likely to predict clinical benefit.

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Imperial Center Family Medicine

MAY 5, 2025

Studies associate the two hours after an episode of rage with a higher risk of adverse cardiovascular events. People with clinical depression often have elevated cortisol levels, potentially leading to high blood pressure over time. Finding healthy emotional outlets is essential.

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FDA Law Blog

DECEMBER 6, 2024

The draft guidance includes FAQs covering topics from across disciplines: regulatory review; chemistry, manufacturing, and controls (CMC); nonclinical and pharmacology/toxicology (PT); clinical; and clinical pharmacology.

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