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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Vascular Physician

AUGUST 23, 2022

Thursday Sept 8, 2022 11:00 - 11:30 am Registration in Foyer on 3rd Floor by Platte River Ballroom Visit with Sponsors in Confluence Room C (30 mins) 11:30 – 12:15pm Lunch/Visit with Sponsors in Confluence Room C (45 mins) 12:15 – 12:20pm Welcome/Introductions in Platte River Room by Barbara Melendez, MD (5 mins) Session 1: 12:20 – (..)

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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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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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Physician's Practice

JUNE 19, 2025

Reynolds Fact checked by Chris Mazzolini Blog Article These essential strategies will enable your practice to safeguard digital assets and ensure compliance. Even innocuous habits— scrolling social media at the nurses’ station —can expose screens to wandering eyes or distract staff from patient care.

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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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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

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

NOVEMBER 20, 2024

However, reprocessing (cleaning and disinfection and/or sterilization) is typically performed by the end user in a healthcare facility rather than part of the manufacturing process. FDA’s suggestion to test the maximum reprocessing cycles for reusable devices is aligned with the recommendations in clause 4.8

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Mesa Family Physician

JUNE 11, 2025

Preventive care is often referred to as the first line of defense in healthcare—and for good reason. 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.

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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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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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FDA Law Blog

JULY 7, 2024

The guidance also reminds readers of the somewhat illusory protection offered by enforcement discretion, noting that “FDA retains discretion to pursue enforcement action for violations of the FD&C Act at any time and intends to do so when appropriate.”

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PEMBlog

JULY 10, 2024

” Emily Labudde, MD, a Pediatric Emergency Medicine fellow at Children’s Healthcare of Atlanta and recent pediatric residency graduate from Cincinnati Children’s discusses the various manifestations of this sexually transmitted infection, and how we can’t miss this very treatable, but sneaky malady.

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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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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. In our current environment, it can feel overwhelming as a healthcare provider to discuss firearms. Carney and I am a pediatric resident at Cincinnati Children’s Hospital Medical Center. I’m here with my co-resident, Dr. Humphrey.

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FDA Law Blog

MAY 3, 2022

By Dara Katcher Levy — A few weeks back, OPDP issued its second Untitled Letter of 2022 (third letter in 2022 overall) to Bausch Healthcare alleging violative DTC and HCP promotional communications for Duobrii (halobetasol priopionate and tazarotene) lotion.

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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.

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GeriPal

APRIL 18, 2024

Skepticism on the ability of predictive models to transform healthcare Consolidation of EHR’s into the hands of a very few companies, and potential for the drug and device industry to influence care delivery by tweaking AI in ways that are not transparent and already a sort of magical black box. Bob: Exactly. It could be anybody.

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