FDA Law Blog

MAY 13, 2024

Gibbs & Ana Loloei & Véronique Li, Senior Medical Device Regulation Expert — FDA has long touted the use of real-world evidence ( RWE ). RWE is “the clinical evidence regarding the usage, and potential benefits or risks, of a medical product derived from analysis of RWD.” By Jeffrey N.

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FDA Law Blog

FEBRUARY 28, 2022

Bauer, Senior Regulatory Drug Expert — Our readers probably know that we value and advocate for patient engagement as an essential component in the development of medical products (see our firm’s commitment here ). The Guidance provides practical advice for device manufacturers to utilize patient engagement in clinical studies.

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FDA Law Blog

SEPTEMBER 11, 2023

Baumhardt, Senior Medical Device Regulation Expert & Adrienne R. Lenz, Principal Medical Device Regulation Expert — On September 6, 2023, FDA announced its latest efforts to modernize the 510(k) process, outlining FDA’s latest improvements to strengthen the 510(k) Program and announcing release of three draft guidance documents.

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The Clinical Problem Solvers

DECEMBER 16, 2020

Our guests explain how we can incorporate race-conscious medicine in clinical settings, medical education, and biomedical/epidemiological research to responsibly recognize and address the harms of racial inequality. These factors include a high-protein diet, muscle mass, creatinine generation, and certain medications. link] Tsai J.

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FDA Law Blog

NOVEMBER 6, 2022

In June 2019, Pfizer sought an OIG advisory opinion to ensure that its proposal would not run afoul of federal law. The Court found that there is at best little utility in interpreting the AKS by reference to the BIS. The Medicare program would pay most of the remaining $225,000 in annual cost. Pfizer’s Petition to SCOTUS.

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FDA Law Blog

NOVEMBER 7, 2024

By Véronique Li, Senior Medical Device Regulation Expert & Jeffrey N. One less utilized method (and for good reason) to gain more certitude is the 513(g) Request for Information. Gibbs — In most instances, it is clear if a product will be considered a “device” under the Federal Food, Drug, and Cosmetic Act (FD&C Act).

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FDA Law Blog

OCTOBER 14, 2021

Food and Drug Administration (FDA) is reminding patients and health care providers that the safety and effectiveness of robotically-assisted surgical (RAS) devices for use in mastectomy procedures or in the prevention or treatment of breast cancer have not been established. In this safety communication, FDA states: The U.S. 21 U.S.C. §

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Physician's Practice

JUNE 25, 2025

These videos are 5 to 10 minutes in length and will provide practical ideas and suggestions that have been tested in his practice or used by other physicians that significantly improve the efficiency and productivity of their medical practices. Dr. Baum was the columnist for American Medical News for more than 25 years.

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FDA Law Blog

JUNE 22, 2022

This matter is the latest in a recent string of large monetary settlements between the government and health care providers involving employee diversion. Lax Controls Provided Employees with Opportunity to Divert. In short, the employees were provided the opportunity to not only commit the crimes but that they went undetected.

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PEMBlog

SEPTEMBER 27, 2023

Identifying the specific type of virus that are causing a child’s symptoms, like rhinovirus vs parainfluenza, is often unnecessary, especially in otherwise healthy children who are managed at home. . · A positive test can provide false reassurance to clinicians and caregivers. antivirals for influenza) or public health recommendations (e.g.,

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The Clinical Problem Solvers

APRIL 5, 2022

Do you have a medical respite center? Dr. Kushel and Mr. Watts remind healthcare providers to speak out about the structural causes of homelessness. This episode was hosted by Sudarshan Krishnamurthy, Jazzmin Williams, and Alec Calac. Calac, Victor A. Our guests emphasize that physicians must be familiar with community resources.

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The Clinical Problem Solvers

FEBRUARY 8, 2023

Between 2007 – 2019, Black individuals experienced a higher death rate for opioid overdose deaths than any other racial or ethnic group. This parallels another process, which is the medicalization of human experiences, especially those relating to childbirth and pregnancy.

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FDA Law Blog

JUNE 7, 2021

Subpart H) pathway in 2014, then issued it as final guidance in January 2019. It is noteworthy that this sentence that no clinical benefit has been established was deemed by FDA as unnecessary for Aduhelm to provide additional context beyond that the approval is based on reduction in amyloid beta plaques.

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GeriPal

AUGUST 25, 2022

I had looked at a research article that had recently evaluated the prevalence of private equity transactions in the hospice market and noted that there was a pretty substantial uptick in the past decade, and really over the course of say around 2015 to 2019. There’s also been some differences in things like staffing.

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PEMBlog

APRIL 26, 2023

I’m Dr. Carney and I am a pediatric resident at Cincinnati Children’s Hospital Medical Center. From 2019 to 2020, the rate of firearm related deaths among children increased by 30%. In our current environment, it can feel overwhelming as a healthcare provider to discuss firearms. Children’s Defense Fund. 2022, March 18).

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FDA Law Blog

JUNE 2, 2023

For 10 high-cost single source covered outpatient drugs selected annually by CMS, manufacturers would be required to respond to a so-called “price verification survey” by providing not only clinical and utilization information about the drug, but also costs of production, distribution, research, and marketing; revenue and profit; and ex-U.S.

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FDA Law Blog

AUGUST 21, 2023

Brand drugs, generic drugs, and medical devices alike have all been the target of state failure-to-warn litigation; in a recent case, OTC acetaminophen is the target. Recall that the funds provided under the Prescription Drug User Fee Acts (PDUFA) are not available to support the agency’s efforts related to monograph drugs.)

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New South Family Medicine and MedSpa

SEPTEMBER 17, 2019

Eating fruit provides excellent health benefits and is part of a healthy plate. Fruits provide nutrients vital for health and maintenance of your body. Fiber containing foods such as fruits help provide a feeling of fullness with fewer calories. Then take a moment to reflect on your unique plate.

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FDA Law Blog

OCTOBER 29, 2023

Since that blog post, an important step forward was the decoupling of the coverage requirement from the FDA Birth Control Guide in the guidance provided by the Department to plans and issuers.

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PEMBlog

APRIL 4, 2024

Be sure to check out our previous posts on: BRONCHIOLITIS , EPIGLOTTITIS , PNEUMONIA , and CROUP The Problem: Free open access medical education (aka FOAM) is great in that it allows for asynchronous, focused learning. Our SOAR review provides readers with a curated list of high-quality blog posts on topics of respiratory infectious disease.

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