FDA Law Blog

MARCH 7, 2024

As a final example, current regulations require a sponsor of an investigational medical device to report to FDA (and others) “unanticipated” adverse events, which are defined in part as “serious,” and sponsors of investigational drugs to report to FDA serious and unexpected suspected adverse reactions.

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Physician's Weekly

JUNE 22, 2025

Investigators concluded that the finalized COS provided a foundation for standardizing outcome reporting in fecal incontinence research, with further work needed to define measurement tools and timing.

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Permanente Medicine

JUNE 23, 2025

This complimentary virtual event will feature a candid, strategic conversation with national health care leaders as they share their insights and best practices from proven value-based care models to help health systems, physician groups, and health plans navigate this critical transformation. .” PT / 11:30 a.m. CT / 12:30 p.m.

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Physician's Weekly

JUNE 15, 2025

This review provides an updated synthesis of the ocular side effects associated with newer classes of targeted chemotherapy agents. Systemic targeted anti-cancer therapies have revolutionized oncology by selectively attacking malignant cells while minimizing systemic toxicity.

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FDA Law

JUNE 18, 2025

The Commissioner will use “specific criteria” to award the vouchers, and information will be provided in the near future on how companies can apply for a CNPV and “indicate their alignment with the FDA Commissioner’s criteria to meet national priorities.” Addressing unmet public health needs.

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Common Sense Family Doctor

JUNE 8, 2025

The historical events depicted in the Academy Award–winning film Oppenheimer are no longer just history; at New Mexico’s Los Alamos National Laboratory, for the first time in decades, the United States has resumed building plutonium cores.

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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. Therefore, the events surrounding this particular Warning Letter preceded the LDT decision. RUO-labeled reagents and materials are often used in LDTs in clinical laboratories.

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Center for Family Medicine (CFM)

JUNE 1, 2025

This is a time when lesbian, gay, bisexual, transgender, and queer people and allies alike unite to support each other, strengthen the community, and celebrate themselves and others with parades and joyous events. 988 provides local call, text, and chat support whenever needed. Talking with friends can help lessen the mental load.

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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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Maine Academy of Family Physicians

JULY 11, 2024

3 Tufts University School of Medicine Maine Track students and 5 University of New England College of Osteopathic Medicine students participated as teachers during the event. Doc4aDay is a community outreach program provided through the Maine Medical Center Department of Medical Education.

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FDA Law Blog

JANUARY 30, 2025

The January 2025 draft guidance, however, provides a more focused discussion of the timing of confirmatory studies and how that might impact approval. These draft guidances also discuss how the Agency plans to interpret whether such a study needs to be underway at the time of approval and, if so, whether it is underway.

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StorytellERdoc

FEBRUARY 10, 2014

Brown didn't probably realize, though, is that as important as his providing a detailed history may be, these obscure observational moments, wordless and symptom-producing, can provide just as much, if not more, information to a treating physician like myself. I am again eager to capture in words these pure moments. Another cough.

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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% Host an Earth Day Community Event Organize a neighborhood clean-up or tree-planting initiative and invite staff, patients, and local schools. Need help planning an event? Contact us today!

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Imperial Center Family Medicine

MAY 12, 2025

The best way to know if your levels fall into the unhealthy range is to get your healthcare provider to check your blood pressure regularly. Do not quit taking prescribed meds unless explicitly instructed by your provider. Maintaining healthy blood pressure levels is essential for heart health.

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Plum Health

OCTOBER 29, 2024

Key Features of Subscription Primary Care Unlimited Visits : You’re generally not charged per visit, so you don’t have to worry about co-pays each time you see your provider. Direct Access to Your Doctor : Many DPC providers limit their patient load, meaning you get more face-to-face time with your doctor, often with little to no wait time.

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Sound Physicians

NOVEMBER 19, 2024

Fostering leadership potential While not every clinician aspires to be a leader , it ’ s crucial to provide avenues for those who do. This unique leadership role provides another layer of leadership to support the medical director and even act as chief in their absence. Enter the associate medical director.

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FDA Law Blog

JUNE 12, 2024

With input from medical professionals, stakeholder, trade associations, and patient advocacy groups, FDA provided a pathway to market for air-conduction hearing aids without a prescription or the involvement of a licensed professional. FDA does, however, expect to issue a report on OTC hearing aid adverse events to Congress by August 2024.

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Physician's Weekly

JUNE 11, 2025

Distributing intake throughout the day has been shown to enhance muscle synthesis, and targeting 90 g/day provides 1.2 The second piece is getting folks to be successful at restricting their calories, which works well when nutrition education and behavioral counseling strategies are combined—and even better when provided in a group setting.

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Myriad Genetics

MAY 20, 2025

It’s encouraging to see patients recognize what we, as healthcare providers, already know—that medications can be an effective option for people struggling with depression, anxiety, and other mental health conditions,” said Dr. Brown. My problems were not going away, and I found myself wishing I could just not be here,” said Ms. “I

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FDA Law Blog

JULY 20, 2021

We previously reported on events that resulted in this rule. FTC concluded that none of the comments provided a compelling basis to change the substantive requirements of the proposed rule. FTC concluded that none of the comments provided a compelling basis to change the substantive requirements of the proposed rule.

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Imperial Center Family Medicine

APRIL 14, 2025

Know Your Baseline Your first cholesterol screening in your 20s or 30s provides a baseline for future test results. Early screening reveals these “silent” health threats that may otherwise go undetected for years until more serious heart issues such as chest pain, heart failure, or events such as heart attacks or strokes arise.

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Permanente Medicine

MAY 20, 2025

” “Whether you’re the call center agent, the receptionist, [or] the lab tech, you participate and you provide the input into innovation,” said Dr. Nguyen. The Southern California Permanente Medical Group is one of the largest medical groups in the nation with more than 8,800 physicians providing care for over 4.8

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FDA Law Blog

FEBRUARY 28, 2024

Prior to FDORA’s enactment, the statute did not provide details on the withdrawal procedures other than offering an opportunity for an informal hearing. Tobolowsky & Michelle L. Without commenting on the merits of the decision, it is an interesting window into how FDA may use these new procedures in practice.

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The Motivated MD

OCTOBER 7, 2024

I am heartbroken for the communities affected by this storm and for our fellow healthcare providers who are either dealing with this in their personal lives or having to navigate recovery as part of their careers. The silver lining of a horrific event like this is the incredible humanity we witness in its aftermath.

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FDA Law Blog

SEPTEMBER 23, 2024

There have already been (with more coming) a slew of 40th anniversary celebration papers, analyses, and events in 2024, including: The Brookings Institution’s Hatch-Waxman at 40 The Association for Accessible Medicines’ Hatch-Waxman turns 40. Is it over the hill? (Or We thought about an interview with Rep. We wanted something different.

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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. While having these things can make life a bit easier and provide you with more practice options, they are not an absolute necessity.

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Plum Health

MAY 19, 2023

While your insurance covers significant events, DPC takes care of routine healthcare needs affordably. It's not insurance but complements various insurance and health share plans to provide comprehensive coverage.

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Vida Family Medicine

AUGUST 26, 2024

Focusing on these broader indicators provides a more accurate picture of your health and helps you make lasting changes that truly benefit your well-being. 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.

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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

APRIL 13, 2025

By Sarah Wicks & Dara Katcher Levy FDAs Office of Prescription Drug Promotion (OPDP) issued its second Untitled Letter of 2025 to Taiho Oncology (Taiho) for a healthcare provider branded website for its drug LYTGOBI (futibatinib). Join us as we break down what went wrong this time. What Happened? The problem?

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FDA Law Blog

FEBRUARY 9, 2024

Overall, the final guidance provides many editorial clarifications as well as some noteworthy updates, including discussions on DHTs that meet the definition of a device, selection of a DHT and rationale for use in a clinical investigation, retention and protection of data collected by DHTs, and DHT updates. By Adrienne R.

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FDA Law Blog

DECEMBER 7, 2022

It takes many years to determine if something provides durable treatment and to what degree it may fade over time. 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.

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CDOCS

MARCH 15, 2021

& We participate within our dental community in educational meetings and events, which builds our trust in the specialist. ’ When working with a case that requires a combination of expertise from the general dentist and specialist, it is our job to be able to explain and provide understanding on all aspects of treatment.

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CDOCS

JANUARY 12, 2021

<p>CEREC design tools are widely used in many dental practices.</p> </p> <p>As CAD/CAM technology continues to develop, dentists are taking advantage of its integration with 3D printing to maximize efficiency in their practices. It saves dentists time and money while attracting patients and adding valuable services.</p>

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BMJ

DECEMBER 16, 2021

It can provide insights into the nature, causes and consequences of change as well as identifying continuity, stability and lack of change. Longitudinal qualitative research (LQR) involves multiple data collection points and is uniquely focused on exploring temporality of experiences. following individual or groups of participants).

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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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FDA Law Blog

JANUARY 18, 2022

The discussion paper provides an overview of FDA’s current approach to regulation of 3D-printed devices. requests for different sizes or geometries after a printed device is examined by a healthcare provider). complaint handling and adverse event reporting processes) and staff trained in the maintenance of equipment.

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