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> Nelson further explains, &ldquo;I believe a key component to success for case acceptance is providing education to my staff and the offices I work with.

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Patients Finance Education Utilities 52

FDA Law Blog

FEBRUARY 28, 2022

The Agency’s goal is demonstrated in its definition of patient engagement: “Patient engagement is defined as intentional, meaningful interactions with patients that provide opportunities for mutual learning, and effective collaborations.” .

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Patients Clinic Medical Patient-Centered 52

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 ).

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Medical Electronics Manufacturing Utilities 64

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. In this safety communication, FDA states: The U.S. The question answers itself. 21 U.S.C. §

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Patient-Centered Healthcare Manufacturing Provider 52

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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Clinic IT Utilities Government 64

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. A negative test can also provide false reassurance. The clinical utility of respiratory viral testing in hospitalized children: a meta-analysis. for bronchiolitis and 1.5%

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Patients Illness Hospital Management 52

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 is Professor of Clinical Urology at Tulane Medical School in New Orleans, Louisiana.

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Patients Private Practice Management Healthcare 52

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. A more Western perspective on health care emphasizes the role of physicians and health care providers and marginalizes the role and contributions of doulas and midwives.

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Community Patient-Centered Mental Health Board-Certified 52

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.

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Clinic IT Private Practice Utilities 98

The Clinical Problem Solvers

APRIL 5, 2022

Dr. Kushel and Mr. Watts remind healthcare providers to speak out about the structural causes of homelessness. Published April 5, 2019. January 18, 2019. The Clinical Problem Solvers Podcast. This episode was hosted by Sudarshan Krishnamurthy, Jazzmin Williams, and Alec Calac. Calac, Victor A. Rothstein, R.

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Community Patient-Centered Emergency Room Medical 52

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.

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Manufacturing Utilities Provider IT 59

GeriPal

AUGUST 25, 2022

And yet, we know little about the clinical experience of people with dementia in hospice. I think that there are some really great for-profit hospices out there that are actually able to provide more services and more open access for patients. People with dementia make up about half of hospice admissions.

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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%. In our current environment, it can feel overwhelming as a healthcare provider to discuss firearms. Thank you for hosting us, Brad!

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Families Family Mental Health Healthcare 52

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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Manufacturing Vaccination Government Diagnosis 59

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).

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Manufacturing Supply Chain Patient-Centered Utilities 98