FDA Law Blog

OCTOBER 16, 2023

discusses several approaches that companies are exploring for use of AI in the diagnosis of Alzheimer’s Disease, including AI-enabled software for retinal scans and identification of genetic triggers. The first article—“Is the Eye the Window to Alzheimer’s?”—discusses Meanwhile, FDA’s AI/ML-focused initiatives continue to expand.

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Priority Physicians

JANUARY 20, 2025

Priority Physicians Provides Care for Musculoskeletal Injuries But before you rush that sprained ankle to urgent care, consider this: At Priority Physicians, we have fellowship-trained sports medicine doctors with the proper credentials to handle musculoskeletal injuries knowledgeably. Scans are expensive and require scheduling.

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Logansport Memorial Hospital

APRIL 23, 2024

In this blog article, Dr. Scott Marsh, our podiatrist here at Logansport Memorial, shares some tips to keep your feet healthy. Early detection and diagnosis can prevent significant issues, including surgery. Wearing sandals around the pool is okay, but avoid wearing them daily as they do not provide adequate support for your feet.

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Common Sense Family Doctor

DECEMBER 14, 2024

A 2019 AFP editorial provided more guidance for estimating and having conversations about life expectancy with older patients. ** This post first appeared on the AFP Community Blog.

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FDA Law Blog

DECEMBER 12, 2022

This blog post describes the medical device determination process and a way of assessing software functions to determine if your software product is subject to FDA regulations. or other similar or related article” which is “intended for use in the diagnosis of disease or other conditions.”

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Plum Health

MAY 19, 2023

It's not insurance but complements various insurance and health share plans to provide comprehensive coverage. This blog post is a general informational guide and does not replace professional medical advice, diagnosis, or treatment. Always consult with a healthcare professional for any medical condition or health concern.

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FDA Law Blog

OCTOBER 6, 2023

There is much to unpack, and we intend to do so in a series of blog posts. Given the potentially massive impact of the proposed changes on a wide range of stakeholders, and indeed on the healthcare system, we strongly encourage interested parties to submit comments, which can be done using the provided link.

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Vascular Physician

JUNE 26, 2022

If your healthcare provider suspects that you could have DVT, they will likely perform a series of tests to provide you with a diagnosis and personalized treatment plan. It can provide an image of the veins in a specific area of your body to display the size and location of blood clots.

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Vascular Physician

NOVEMBER 28, 2023

Other signs of lymphedema include: Feeling tightness or heaviness in the affected area Thickening of the skin Frequent infections It is best to schedule an appointment with your healthcare provider as soon as you notice one or more symptoms of lymphedema. Early diagnosis could mean a more effective treatment plan.

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ABIM

MAY 18, 2025

and Globally IBD is no longer a rare diagnosis. This burden of the disease is being felt by patients and healthcare providers. I was living with pain, confusion, and shame, and I didn’t yet have the words or the diagnosis to explain it to others. The Rising Incidence of IBD in the U.S. It is now a growing global health issue.

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FDA Law Blog

DECEMBER 4, 2023

Houck — Separate decisions by federal district courts in Texas and Puerto Rico in the past two months provide cautionary tales for every pharmacy and wholesale distributor dispensing or distributing controlled substances. Providers should be aware of the other drugs prescribed to their patients. By Larry K. Complaint ¶ 60.

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Vascular Physician

DECEMBER 21, 2022

Other factors that could make you more likely to be affected by RAS include: High blood pressure High cholesterol Diabetes Smoking Unhealthy diet Men over the age of 45 and women over the age of 55 Obesity What Are the Symptoms, Diagnosis, and Complications? In most cases, RAS does not exhibit any noticeable signs or symptoms.

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Vascular Physician

DECEMBER 11, 2023

Diagnosis and Treatment of AVFs AVFs are diagnosed by a healthcare provider. If the healthcare provider suspects you have an AVF, they will request other tests to confirm it. If the healthcare provider suspects you have an AVF, they will request other tests to confirm it.

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FDA Law Blog

FEBRUARY 2, 2025

Please note these helpful Nonresident Pharmacy Licensure FAQs California Pharmacists can continue to provide oral therapeutics to patients after a positive Covid-19 diagnosis. California pharmacists are still able to provide the oral therapeutics without requiring you to visit your primary care physician through January 1, 2026.

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Vascular Physician

OCTOBER 24, 2022

This can make it difficult for individuals to get a proper diagnosis and the treatment they need to prevent the condition from progressing into something more serious. If your healthcare provider suspects that you could have May-Thurner syndrome, they will likely use noninvasive imaging studies to diagnose you.

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Vascular Physician

NOVEMBER 28, 2023

Some PAD complications are more likely to occur in individuals who also have diabetes, including: Stroke Heart attack Non healing wounds Diagnosis and Treatment of PAD Since PAD may not produce symptoms, a healthcare provider is necessary in diagnosing this condition.

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Vascular Physician

JUNE 27, 2021

blog h2 { margin-top: 1.25rem; } Varicose veins are quite common and often lead to pain, embarrassment and possibly further health issues. For proper diagnosis, a vascular specialist will complete a comprehensive evaluation that includes an ultrasound to detect varicose veins, evaluate blood flow and determine the efficiency of vein valves.

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FDA Law Blog

OCTOBER 30, 2022

FDA is also proposing updates to Section III of the 2018 Breakthrough Devices Program guidance to clarify the designation considerations for the first breakthrough criterion—whether a device provides for “more effective” treatment or diagnosis.

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PEMBlog

AUGUST 30, 2023

This is a blog post and a podcast episode 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

AUGUST 23, 2022

These practical benefits are in marked contrast to molecular COVID-19 tests that are used for definitive diagnosis and are generally expected to detect the SARS-CoV-2 virus at least 95% of the time when someone is infected. After two negative tests, you should consider a molecular test, or call your healthcare provider.

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PEMBlog

MAY 20, 2025

I think it’s very important, almost an obligation, for us to provide outreach and education to our community ED colleagues so that they are given the tools needed to provide the right imaging to the right patient at the right time. And so we routinely do outreach with our community providers.

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PEMBlog

OCTOBER 2, 2024

I’ll dive into the latest clinical practice guidelines and discuss evidence-based approaches to diagnosis and treatment. Join me as I scope out the nuances of gastroesophageal reflux and gastritis and provide practical insights for clinicians in the emergency setting. Understanding dyspepsia and its clinical presentation.

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FDA Law Blog

SEPTEMBER 21, 2022

This led to delays in releasing a uniform policy and templates for COVID-19, as well as many other problems (see blog post chronicling some of the challenges here ). Finally, the policy emphasizes the importance of validation data, and states that FDA is providing EUA templates. academic medical center laboratories).

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FDA Law Blog

MAY 19, 2025

Opioid prescriptions for high dosages and quantities, including prescriptions that individually or in combination, provide patients with daily dosages of greater than or equal to 300 Morphine Milligram Equivalents (MMEs). 81, 89, 251.

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PEMBlog

SEPTEMBER 27, 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. isolation for SARS-CoV-2).

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FDA Law Blog

MARCH 16, 2023

The test is intended for use as an aid in the diagnosis of SARS-CoV-2 infections (COVID-19) in symptomatic individuals when tested at least twice over three days with at least 48 hours between tests. In the best tradition of teasers, keep reading our blog. symptomatic) when testing is started within 6 days of symptom onset.

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FDA Law Blog

APRIL 20, 2021

Remove non-device software functions intended for storing and retrieving, so that a medical image storage device is a hardware device that provides electronic storage and retrieval functions for medical images. Remove non-device software functions intended for transmitting, receiving, and displaying data. Medical Image Storage Device.

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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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FDA Law Blog

SEPTEMBER 26, 2024

In particular, CDRH touts its Breakthrough Devices Program, which it advertises as a “program for certain medical devices and device-led combination products that provide for more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions.

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FDA Law Blog

JUNE 28, 2023

In September 1998, CVM published Policy and Procedures Manual (PPM) 1240.3605, Regulating Animal Foods With Drug Claims , which provides guidance on how CVM regulates substances for animals. The proposed amendments to the FDC Act would provide CVM with the needed authority.

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FDA Law Blog

JANUARY 6, 2022

220 and was described on HP&M’s blog here. Clinical treatment facility” is defined as “a medical setting, other than a hospital, that provides detoxification, risk reduction, outpatient treatment and care, residential treatment, or rehabilitation for substance use, pursuant to licensure or certification under State law.”

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FDA Law Blog

FEBRUARY 27, 2023

The rule would permit a practitioner using a telemedicine encounter to prescribe controlled substances without an in-person visit under various situations involving both an audio-visual telehealth evaluation, or an in-person evaluation performed by a “referring” provider. Proposed practitioner recordkeeping obligations.

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FDA Law Blog

JANUARY 6, 2022

220 and was described on HP&M’s blog here. Clinical treatment facility” is defined as “a medical setting, other than a hospital, that provides detoxification, risk reduction, outpatient treatment and care, residential treatment, or rehabilitation for substance use, pursuant to licensure or certification under State law.”

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FDA Law Blog

JUNE 22, 2023

To obtain clearance of an OTC home IVD, a sponsor must provide the usual suite of analytical and clinical validation that would be required for any IVD, demonstrating adequate repeatability, stability, sensitivity, specificity, and so on. HbA1c, diagnosis of a particular virus, etc.). seeking treatment).

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Rao Doctor

APRIL 3, 2025

In case you have missed it, click below to read- FEVER FAQ- Part 1 Fever Diagnosis: How is your health assessed? When assessing a fever, we doctors employ a systematic approach to ensure accurate diagnosis and effective management. Understanding the patient’s medical history is crucial for an accurate diagnosis.

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FDA Law Blog

JANUARY 26, 2022

By Dara Katcher Levy — We are working to keep up with OPDP’s posts over the past few weeks and a blog on its most recent letter to Lilly is forthcoming! With apologies to Rob Base and DJ EZ Rock , it took more than “two” to get this Emgality DTC TV commercial right (insert snare drum here please).

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Vascular Physician

NOVEMBER 5, 2023

These include: Endometriosis Adenomyosis Ovarian cysts Chronic pelvic inflammatory disease (PID) Finding a healthcare provider who you can trust and who is willing to perform the necessary tests to differentiate this diagnosis from other conditions that can also cause pelvic pain is the best way to achieve an accurate diagnosis.

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