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Clissold — The trio of CDER, CBER, and CDRH released a new draft guidance titled “ Use of Data Monitoring Committees in Clinical Trials ” that revises the 2006 guidance “Establishment and Operation of Clinical Trial Data Monitoring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

NOVEMBER 20, 2024

Objective: To examine the impact of discontinuation of statins compared to continuation on clinical outcomes. Population Studied: Adults ≥18 years Intervention/Instrument: Discontinuation of statin medications Outcome Measures: All-cause mortality, cardiovascular (CV) mortality, and CV events (e.g., stroke and MI).

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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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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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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.” Easily interpreted clinical trial endpoints (e.g.,

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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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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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Annals of Family Medicine

NOVEMBER 20, 2024

Context Ten percent of patients using prescription drugs experience adverse drug events (ADE). One proposed reason is the lack of knowledge about PGx among clinicians slowing down the potential for clinical implementation, showing the main barrier to implementation is lack of healthcare professionals’ education.

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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. Fostering leadership potential While not every clinician aspires to be a leader , it ’ s crucial to provide avenues for those who do. Excellent leaders rise to the occasion when opportunities are open and available to them.

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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

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. The Draft Guidance provides specific examples illustrating the application of each scenario. 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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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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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). The problem? As a single-arm trial (i.e.,

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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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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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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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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. It can help us understand the process of implementing new practices in primary care in the context of clinical trials and in routine clinical care. the COVID-19 pandemic).

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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. Considering FDAs new authority to specify the conditions for such confirmatory trials (e.g.,

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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

JULY 26, 2021

The conference is billed as the premier event to provide folks with a roadmap to navigate the difficult terrain of FDA regulatory law. And like a lot of conferences over the past 18 months, the ACI conference format has changed from a live, in-person event to an interactive, virtual conference.

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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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Vida Family Medicine

AUGUST 26, 2024

From specialized obesity clinics to online services offering quick prescriptions, the options can feel overwhelming. 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. But how do you know what is safe and who to trust?

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FDA Law Blog

JANUARY 12, 2025

Sasinowski On December 5, 2024, FDA published a new draft guidance on accelerated approval providing a much needed and substantial update to its guidance on the pathway. an intermediate clinical endpoint) and that is reasonably likely to predict an effect on irreversible morbidity or mortality or other clinical benefit.

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FDA Law Blog

DECEMBER 21, 2022

Baumhardt, Senior Medical Device Regulation Expert — In our previous blog post , we provided a flowchart for the Digital Health Policy Navigator’s process so that our blog readers can quickly review the seven steps in determining whether their product’s software functions may be potentially the focus of FDA oversight.

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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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FDA Law Blog

JANUARY 5, 2023

Claud — As we turn into the New Year, we offer a few items of interest in digital and telehealth regulation, enforcement, and compliance that may provide some helpful guideposts for stakeholders. Digital providers and manufacturers not only have the concerns of the FDA to consider, but those of the FTC as well. By John W.M.

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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. In this scenario, FDA is interested in the possibility of frequent design changes that may occur in response to clinical feedback (e.g., use in education, construction, art, and jewelry).

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FDA Law Blog

JANUARY 2, 2023

Hosted by American Conference Institute, the FDA Boot Camp returns for its 40th iteration with the continued intent of providing an essential working knowledge of core FDA concepts, and real-world examples that will help you to excel in your everyday practices. Clinical trials for drugs and biologics.

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FDA Law Blog

MARCH 8, 2023

Acknowledgement 3 notifies the submitter that the submission was either successfully loaded into CDRH’s adverse event database or that the submission contained errors, which will be specified in the letter. Acknowledgement 2 indicates that the submission reached CDRH.

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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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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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Management DO Family Medicine Hypertension 52

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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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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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

JANUARY 18, 2022

The discussion paper provides an overview of FDA’s current approach to regulation of 3D-printed devices. In this scenario, FDA is interested in the possibility of frequent design changes that may occur in response to clinical feedback (e.g., use in education, construction, art, and jewelry).

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