East Cary Family Physicians

OCTOBER 20, 2023

In this blog, we’ll explore the importance of Breast Cancer Awareness Month, focusing on early detection, prevention, and the vital role of regular screenings in women’s healthcare. Clinical Breast Exams: Scheduling regular clinical breast exams is another essential component of early detection.

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Dr. Zaar

MAY 20, 2025

In this blog, we’ll answer the most common questions and explain why more people are choosing online hormonal therapy services across Canada. During the appointment, you discuss your symptoms and clinical records. Today, virtual care provides quick, convenient access to expert endocrinologists. What Is Hormonal Therapy?

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FDA Law Blog

MARCH 2, 2022

The new idea is for NIH’s ITAP program to pivot to serial screening. NIH has been in communication with FDA to finalize a standardized clinical protocol for this purpose. With a serial screening study, however, multiple samples are collected by the participant over a few days. That strategy has failed, too. What should FDA do?

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FDA Law Blog

SEPTEMBER 29, 2023

For more than 30 years, FDA has asserted that it has jurisdiction to regulate LDTs as medical devices and clinical laboratories as manufacturers. As we have blogged about extensively over the years, FDA has initiated, but not completed, many efforts through different means to create a regulatory framework for LDTs.

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FDA Law Blog

NOVEMBER 6, 2023

Admittedly, BiMo inspections (into items like adequacy of bioequivalence data, consistency of clinical trial data with medical records, and compliance with clinical trial protocols) lend themselves better to an RIE than assessing manufacturing compliance with regulatory requirements.

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PEMBlog

AUGUST 28, 2023

There will be episodes of PEM Currents: The Pediatric Emergency Medicine Podcast, blog posts here on PEMBlog, articles from Don’t Forget the Bubbles , videos, and more! Do not obtain screening laboratory tests in the medical clearance process of pediatric patients who require inpatient psychiatric admission unless clinically indicated.

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FDA Law Blog

AUGUST 23, 2022

The 80% sensitivity requirement for antigen tests has yet to be explained either scientifically or clinically by the Agency. While this was a step in the right direction, only the tests whose clinical studies occurred during the Omicron surge had this stipulation included in their labeling.

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PEMBlog

SEPTEMBER 6, 2023

This is a blog post designed to disseminate the important work of Choosing Wisely , an initiative of the the American Board of Internal Medicine Foundation, the goal of which is the spark conversations between clinicians and patients about what tests, treatments, and procedures are needed – and which ones are not. Health Aff (Millwood).

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FDA Law Blog

OCTOBER 10, 2023

By Philip Won & Véronique Li, Senior Medical Device Regulation Expert — As we recently blogged , FDA released three draft guidance documents to help enhance the predictability, consistency, and transparency of the 510(k) program. One of these documents focuses on “ Evidentiary Expectations for 510(k) Implant Devices.”

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FDA Law Blog

OCTOBER 5, 2022

Instead, it will go through a virus scanning and technical screening process to verify that eSTAR responses accurately describe the device and there is at least one applicable attachment per relevant attachment-type question. eSTAR will be mandatory October 1, 2023 for all 510(k) submissions and subsequent supplements and amendments (e.g.

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FDA Law Blog

JULY 10, 2023

In this blog post, we will first briefly outline the procedural steps in the 510(k) review process for medical devices. However, the strategy of addressing the AI request presented in the next section of this blog post applies to all three types of 510(k)s. FDA Day (in calendar days) FDA Actions Day 1 FDA receives 510(k) submission.

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FDA Law Blog

NOVEMBER 28, 2023

Gibbs — Shortly before the Thanksgiving holiday, FDA announced with no fanfare that it would be holding a Molecular and Clinical Genetics Panel meeting this Wednesday November 29. By Allyson B. Mullen & Jeffrey N. It is well known in the industry that FDA has been skeptical of multi-cancer (sometimes also referred to as pan-cancer) tests.

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FDA Law Blog

NOVEMBER 2, 2023

Regarding screening for risk of liver injury: “Total and/or neutralizing antibody titers are screened in many clinical studies, but how such testing is performed, the cut-offs, and the acceptance criteria are all variables that may need standardization.”

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Provider Screening IT Government 59

PEMBlog

SEPTEMBER 13, 2023

This is a blog post designed to disseminate the important work of Choosing Wisely , an initiative of the the American Board of Internal Medicine Foundation, the goal of which is the spark conversations between clinicians and patients about what tests, treatments, and procedures are needed – and which ones are not.

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FDA Law Blog

NOVEMBER 20, 2024

Exhaustive extraction in these solvents can lead to high levels of product degradation or increased levels of extractables found in the chemical data, which is not expected during clinical use, and can often result in a TRA with a negative or inconclusive outcome.

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FDA Law Blog

MAY 25, 2022

Javitt — On April 19, FDA issued a safety communication regarding genetic non-invasive prenatal screening, commonly referred to as non-invasive prenatal tests or NIPT ( here ). NIPT are intended to screen for genetic abnormalities in a fetus. Mullen & Jeffrey N. Gibbs & Gail H.

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FDA Law Blog

MAY 17, 2021

suited for, like back to work screening. 19 LDTs 10 months ago, but it has deprioritized EUAs for virtually all PCR tests that must be sent to laboratories (even those that are not LDTs). The hot ticket these days is rapid antigen testing to satisfy other testing priorities that PCR testing is less well?suited

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Common Sense Family Doctor

MAY 30, 2025

The US Preventive Services Task Force , the American Academy of Family Physicians , and the American College of Chest Physicians recommend annual low-dose computed tomography (CT) screening for adults 50 to 80 years of age who have at least a 20 pack-year smoking history and currently smoke or have smoked within the past 15 years.

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FDA Law Blog

MAY 17, 2021

suited for, like back to work screening. 19 LDTs 10 months ago, but it has deprioritized EUAs for virtually all PCR tests that must be sent to laboratories (even those that are not LDTs). The hot ticket these days is rapid antigen testing to satisfy other testing priorities that PCR testing is less well?suited

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Manufacturing IT Screening Medical 40

Mesa Family Physician

JUNE 11, 2025

In this blog, we’ll break down what preventive care involves, explore its relationship with short-term health insurance, and explain why it’s a critical part of staying healthy at any stage of life. Think vaccinations, annual checkups, screenings for blood pressure or cholesterol, and lifestyle counseling. What Is Preventive Care?

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GeriPal

JANUARY 18, 2024

After discussing screening options for substance use disorder, we go on to talk about both the treatments for it and the issues that arise. And you wrote, actually, a beautiful GeriPal blog about it a while ago. Who do we have with us today? Katie, welcome back to GeriPal. So, I don’t think we should have these silos.

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FDA Law Blog

NOVEMBER 18, 2021

A positive result, however, is treated as a screen. That is just another way of saying, however, that the rapid antigen tests are best positioned as a screening tool. These tests could have been a valuable screening tool for COVID during the past year or so. A follow up laboratory?run run molecular diagnostic (RT?PCR)

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Vascular Physician

MARCH 29, 2022

While not as common as aortic artery aneurysms (AAA), the risk of mortality from PAAs necessitate a familiarity with the correlating clinical signs and symptoms. Consequently, screening for additional aneurysms upon diagnosis is highly recommended. Patient Presentation: The onset for PAA is typically insidious and asymptomatic.

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FDA Law Blog

MARCH 13, 2023

Who better than people living with a condition to inform drug companies, physicians, academics, and the FDA on what it is like to live with their condition, what symptoms most impact their lives, what goes into their decision about whether to participate in a clinical trial, and what kind of treatment effects would be most meaningful to them?

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FDA Law Blog

FEBRUARY 22, 2022

The NIH screens manufacturers to ensure they have reputable tests already in use in other countries with good supporting test data. Additionally, the NIH assists with all the analytical and clinical testing, using protocols already vetted with FDA. This testing is done by testing labs and clinical research organizations (CROs).

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Noreta Family Medicine

APRIL 17, 2024

Other family doctors only see patients in their clinics. There are lab tests, imaging studies, vaccines, and screening questions for people in different age groups, as well as for folks with certain lifestyle habits. The broad basis of our training allows family doctors to follow their interests, which is really nice!

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FDA Law Blog

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). .

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FDA Law Blog

NOVEMBER 29, 2022

CDC Clinical Practice Guideline for Prescribing Opioids for Pain — United States, 2022. We blogged on the 2016 guideline here in March 2016, and the proposed guideline here on March 18th). Expected clinical benefits should be weighed against risks before beginning therapy. Dowell D, Ragan KR, Jones CM, Baldwin GT, Chou R.,

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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.

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PEMBlog

MARCH 27, 2024

She is a member of the Clinical Genome Resource Inborn Errors of Metabolism (IEM) Clinical Domain Working Group, where as a biocurator she assesses the pathogenicity of variants in IEM-associated genes to facilitate expedited genetic diagnosis for IEMs. On clinical presentation. I will take a comment on Facebook or the blog.

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PEMBlog

APRIL 26, 2023

Today, we are going to discuss firearm safety and ways to screen for it in both the ED and clinic settings. Carney and I am a pediatric resident at Cincinnati Children’s Hospital Medical Center. I’m here with my co-resident, Dr. Humphrey. Thank you for hosting us, Brad!

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GeriPal

APRIL 18, 2024

I remember walking through San Francisco Airport with Bob, we just happened to be there at similar times, and saying, “Eric and I are thinking about starting a blog.” And you say, “Okay, that’s fine, but can it really … What about a real live clinical situation?” That is the first clinical use case.

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FDA Law Blog

APRIL 7, 2025

Zenrelia promotional materials also included claims about clinical data that the Agency found actionable. While there is some animal-related risk information included in superimposed text at the bottom of the video screen for a portion of the video.

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FDA Law Blog

NOVEMBER 8, 2022

Torres also shared that the eSTAR program, which we most recently blogged about here , is being developed with Health Canada. To paraphrase from our blog post , EUAs are triggered by an EUA declaration; FDA will publish advanced notice for an EUA declaration and provide a 180 day notice before the implementation of the transition plan.

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