FDA Law Blog

MAY 13, 2024

FDA has even gone so far as to maintain that the “real-life clinical performance of a medical product might be more clearly demonstrated through RWD/RWE because a controlled clinical trial often cannot evaluate all applications of a product in clinical practice across the full range of potential users.”

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CDOCS

MARCH 15, 2021

Patients depend on our clinical knowledge as well as our recommendations and relationships with our specialist partners.</span></span></p> By the utilization of patient financing strategies, we can help to facilitate a means of affordability for the everyday patient.</span></span></p>

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FDA Law Blog

FEBRUARY 28, 2022

address common questions and misconceptions about collecting and submitting to FDA patient engagement information regarding the design and conduct of a medical device clinical study.”. What would be the potential benefits if companies prospectively design medical device clinical studies with input from diverse patient advisors?

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FDA Law Blog

AUGUST 4, 2022

On June 27, 2019, Pfizer sought an OIG advisory opinion to ensure that its proposal would not run afoul of federal law. Pfizer, Inc. Department of Health and Human Services et al. July 25, 2022. Whether the Beneficiary Inducement Statute (BIS) is relevant to interpreting the AKS (essentially, no). Pfizer appealed to the Second Circuit.

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FDA Law Blog

SEPTEMBER 11, 2023

More recently, in 2019, FDA announced a push for predicate modernization ( link ) following a 2018 plan to modernize the 510(k) program by eliminating use of old predicates, sunsetting older predicates, and establishing the Safety and Performance Based Pathway ( link ). Baumhardt, Senior Medical Device Regulation Expert & Adrienne R.

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FDA Law Blog

FEBRUARY 2, 2023

Since 1962, the FD&C Act has authorized FDA to require that sponsors of clinical trials submit data from “preclinical tests (including tests on animals)” in order to demonstrate that their drug is safe enough to advance to testing in humans. adequate to justify the proposed clinical testing.” 21 U.S.C. § 355(i)(1)(A). 42 U.S.C. §

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FDA Law Blog

OCTOBER 14, 2021

Rather, FDA seems intent on regulating RAS devices almost as if they were therapeutics responsible for long term clinical outcomes. It is well out of bounds for FDA to regulate them as if they were a determinant of long term clinical outcomes. Gone are the days of tool type indications for this type of device. 21 U.S.C. §

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PEMBlog

SEPTEMBER 27, 2023

The diagnosis of a virus illness is generally made clinically with a history and clinical exam and does not require confirmatory testing. We understand many families request this test and we urge you to talk with them about these recommendations so we can move to reducing the number of clinical tests that will not change management.

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Physician's Practice

JUNE 25, 2025

Dr. Baum is Professor of Clinical Urology at Tulane Medical School in New Orleans, Louisiana. Dr. Baum is the author of Marketing Your Clinical Practice-Ethically, Effectively, and Economicall y, which is in its 4th edition, has sold over 175,000 copies and has been translated into Spanish. About Neil Baum, M.D.

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FDA Law Blog

JUNE 7, 2021

Subpart H) pathway in 2014, then issued it as final guidance in January 2019. However, the FDA guidance goes on to say in some cases, additional context is needed by specifically inserting a sentence in the indications statement that: no clinical benefit has been established. This has been a decision we’ve been closely following.

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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. Dr. Jordan then questions the utility and continued operation of methadone clinics, especially as the United States largely moves on from the COVID-19 pandemic.

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The Clinical Problem Solvers

APRIL 5, 2022

Published April 5, 2019. January 18, 2019. The Clinical Problem Solvers Podcast. Our guests remind us to ask our patients about their housing status using non-judgmental and non-stigmatizing language. Watts described how life expectancy among those experiencing homelessness is 20-30 years shorter than those with stable housing.

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FDA Law Blog

SEPTEMBER 30, 2024

CMS did not finalize the price verification survey, which would have required manufacturers of 10 costly drugs selected annually to provide clinical information as well as information on production, distribution, research, and marketing costs, revenue and profit, and ex-U.S. pricing, among other things. See 42 U.S.C. 1396r-8(b)(3)(C)(iii).

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GeriPal

AUGUST 25, 2022

And yet, we know little about the clinical experience of people with dementia in hospice. Second, Hospice was originally designed for patients with advanced cancer, but the fastest growing admitting diagnosis is dementia. People with dementia make up about half of hospice admissions. But before we do, I think somebody has a song request.

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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. From 2019 to 2020, the rate of firearm related deaths among children increased by 30%. 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

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

SEPTEMBER 13, 2021

A May 2019 CMS final rule that would have required drug TV advertisements to disclose the WAC of the drug was challenged by a group of pharmaceutical companies and vacated on statutory grounds by the D.C. Medicare negotiation authority; encourage biosimilars and generic drug utilization). Last Thursday, the U.S.

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