East Cary Family Physicians

JULY 26, 2023

In this blog, we will explore the significance of regular health check-ups and how they contribute to your overall well-being. Regular health check-ups are proactive visits to your healthcare provider when you are not experiencing any specific symptoms or ailments. What are Regular Health Check-ups?

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Preventative Care Preventive Care Mental Health Healthcare 52

Noreta Family Medicine

MARCH 26, 2025

You Know DPC is working when… I decided to do something a little different in this blog. I’ve written blogs that discuss my perspective on why Direct Primary Care (DPC) is helpful to both patients and physicians in Columbia, SC (and beyond!). At Noreta, we provide care that considers patients’ health and finances.

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Primary Care Appointment DO Family Medicine 52

Common Sense Family Doctor

DECEMBER 14, 2024

Concerns about overdiagnosis of clinically insignificant prostate cancer through prostate specific antigen (PSA) screening motivated the 2018 American Academy of Family Physicians’ (AAFP) recommendation against routine screening for prostate cancer. Explaining the AAFP’s position, Drs.

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Routine Screenings Screening Complication Diagnose 52

East Cary Family Physicians

FEBRUARY 27, 2024

Insights from East Cary Family Physicians In this blog, we’re diving into one of the most prevalent health conditions worldwide: diabetes. Whether you’re newly diagnosed, caring for someone with diabetes, or seeking to enhance your knowledge, this guide aims to provide valuable insights and practical tips. What is Diabetes?

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Diabetes Management Family Physician Individual 52

East Cary Family Physicians

JANUARY 30, 2024

In this blog post, we’ll explore the importance of vision screenings, especially during Glaucoma Awareness Month, and how they play a crucial role in preserving your eyesight. Regular vision screenings are essential to catch glaucoma early, allowing for timely intervention and the preservation of vision.

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Dr. Zaar

MAY 20, 2025

Today, virtual care provides quick, convenient access to expert endocrinologists. In this blog, we’ll answer the most common questions and explain why more people are choosing online hormonal therapy services across Canada. If you do not have coverage, many online platforms provide inexpensive self-pay options.

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FDA Law Blog

MARCH 2, 2022

The new idea is for NIH’s ITAP program to pivot to serial screening. With a serial screening study, however, multiple samples are collected by the participant over a few days. In fact, FDA has authorized a few devices with serial screening claims based on promises by the companies to conduct the studies post-authorization.

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Screening Provider IT Patients 40

Vascular Physician

APRIL 22, 2024

Whether you are showing signs of a vascular concern, have been diagnosed with a disease, or are striving to prevent a vascular illness from occurring in the future, a vascular ultrasound can give your healthcare provider a clear image of how well blood is flowing to the organs and tissues throughout your body.

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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. Mammograms: Mammograms are the gold standard in breast cancer screening.

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FDA Law Blog

NOVEMBER 20, 2024

The draft guidance provides recommendations for collection and reporting of chemical characterization data and discusses the topics of information gathering, test article extraction, chemical analysis, and data reporting.

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FDA Law Blog

SEPTEMBER 29, 2023

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. which are offered for a wide variety of clinical applications from consumer health testing to cancer screening. This proposed rule is a long-time coming.

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Family Physicians of Greeley

MAY 17, 2023

In this blog, we will explore effective strategies for improving mental health and nurturing a positive mindset. Create a relaxing bedtime routine, avoid screens before bed, and ensure your sleeping environment is comfortable and conducive to restful sleep. Maintaining good mental health is essential for our overall well-being.

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FDA Law Blog

SEPTEMBER 17, 2023

For example, device sponsors can request a meeting with an FDA review team by submitting a pre-submission to CDRH (see our recent blog on the minor updates to the Pre-Submission Guidance). Once your request for an in-person or hybrid meeting is agreed upon, you are expected to provide a list of in-person and virtual attendees.

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Screening Transportation Provider Electronics 59

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

OCTOBER 24, 2023

It also presents specific questions to collect data from the submitter and provides links to relevant regulations and guidance documents. To learn more about our experience with the eSTAR for 510(k)s, check out our previous blogs ( here , here ). 860.230.

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Medical Electronics Provider Screening 52

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

JUNE 8, 2023

A teleconference will be conducted by voice only with no projection of presentations or use of video/camera; a videoconference would involve sharing a screen so that a presentation can be viewed by all participants and/or involve the use of video. An estimated timeline for the return of in-person meetings has not been provided by CDRH.

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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.

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Lab Testing Medical Patients Mental Health 52

FDA Law Blog

AUGUST 23, 2022

After two negative tests, you should consider a molecular test, or call your healthcare provider. If the third test is negative, you should test again with an antigen test, or get a laboratory molecular-based test, or call your healthcare provider. If the second test is negative, you should test again 48 hours after the second test.

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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. The submitter would select “Additional Information” in eSTAR and see a pop up that provides information on next steps.

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Electronics Medical Screening IT 45

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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Manufacturing Engineering Clinic Patients 45

FDA Law Blog

NOVEMBER 28, 2023

The notice ( here ) indicates that FDA plans for the panel to “discuss and make recommendations on the design of multi-cancer detection (MCD) in vitro diagnostic devices (tests) as well as potential study designs and study outcomes of interest that could inform the assessment of the probable benefits and risks of MCD screening tests.”

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Relationship Screening IT Clinic 64

FDA Law Blog

NOVEMBER 2, 2023

These meetings have a question-and-answer format to provide clarity to sponsors about the particular topics at hand. By collaborating with the private sector, the hope is that FDA can leverage the expertise that such close familiarity engenders and can provide sponsors with some level of clarity and consistency for their development programs.

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Provider Screening IT Government 59

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.

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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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Patients Screening Illness Physicals 52

FDA Law Blog

DECEMBER 6, 2023

Tests such as genetic testing of prospective parents, prenatal screening, cancer prognosis, and testing for rare diseases play a critical role in the health care system. Although the sources cited by FDA differ, there is a common denominator: FDA never acknowledges the existence of contrary evidence.

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Engineering Medical Complication Screening 59

FDA Law Blog

FEBRUARY 7, 2022

Further, though any relevant discussion is redacted, the Untitled Letter suggests that FDA had previously provided comments to Lilly about its Trulicity promotion more generally. Companies need to be aware of who is consuming their social media content and how it is being consumed.

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IT Diabetes Screening Provider 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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Illness Preventative Care Preventive Care Insurance 100

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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Screening Healthcare IT Manufacturing 98

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. I mean, the simple answer is, yes, we should be screening people for substance use disorder. What is it called?

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Illness Patient-Centered Screening Clinic 137

PEMBlog

MAY 15, 2023

Our role as providers is to identify the patients who have a life-threatening etiology to their syncope. The majority of these are cardiac and so today we will review what to look for in your screening ECG. “What is the yield of screening echocardiography in pediatric syncope? Larkin, John, et al. Brugada Syndrome.”

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Utilities Screening Physicals Medical 97

Noreta Family Medicine

APRIL 17, 2024

Part 2 Here are some frequently asked questions I get as a Primary Care Provider. Therefore, family physicians are trained to do minor surgical procedures in the office, care for kids and adults, provide various GYN services, among many other comprehensive services for patients. What is primary care?

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FDA Law Blog

JULY 7, 2024

To be sure, Table 2 provides a handy visual of the categories of LDTs, the timeline for phaseout, and the scope of enforcement discretion for each test category. However, the guidance provides no new information on how FDA expects laboratories to implement these new requirements.

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Manufacturing Provider Physicals Electronics 64

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. The NIH also only accepts manufacturers into the program if they can demonstrate the ability to provide high volumes (e.g., 20 million / month or more) of tests to the American market. What should be done?

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Manufacturing Screening Provider Clinic 52

FDA Law Blog

NOVEMBER 29, 2022

We blogged on the 2016 guideline here in March 2016, and the proposed guideline here on March 18th). Clinicians should review state Prescription Drug Monitoring Program (“PDMP”) data and toxicology screening to assess concurrent substance use disorder and overdose. 2022 Guideline at 15. (We 2022 Guideline at 3. Recommendation 9. .

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Patients Patient-Centered ER Individual 52

FDA Law Blog

JULY 9, 2024

We’ve blogged about some of FDA’s efforts to increase diversity in clinical trials previously, and the Draft Guidance itself describes a variety of these efforts. FDA encourages sponsors to consult patients and healthcare providers to assist in developing such strategies. enrolled participants, and these goals must be based on the U.S.

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FDA Law Blog

MARCH 13, 2023

My experience with gene therapy transformed a parent’s worst nightmare – the threat to my child’s health – to the greatest gift I could ever receive – a new chance for a healthy life for him.

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