FDA Law Blog

JUNE 7, 2021

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. be “reasonably likely to predict” ultimate clinical benefit). So how did we get here?

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Medical Xpress

JUNE 8, 2025

While many of these procedures provide critical care, we know they are acutely painful. Provided by The Conversation This article is republished from The Conversation under a Creative Commons license. The content is provided for information purposes only. During this time, they receive up to 16 painful procedures every day.

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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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Manufacturing Vaccination Government Diagnosis 59

FDA Law Blog

AUGUST 21, 2023

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.) Liability is precisely why the vaccine market shrunk so significantly in the 1980s, going from 26 manufacturers to 4, after lawsuits claiming $3.5

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The Clinical Problem Solvers

MARCH 31, 2021

The Global COVID-19 Response Must Be Anti-Racist An anti-racist COVID-19 response means that quality care, quality vaccines, and quality public health information must be provieded to all. From social distancing to contact tracing to vaccin distribution, every step should be considered through an anti-raicst framework.

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Family Medicine Initiative

APRIL 10, 2024

Having Your Own Long-Term GP Can Save Your Life Patients who choose a GP rather than a specialist as their primary care provider have a 19% 8 lower mortality and produce 22% 9 -33% 8 lower healthcare spending. GPs Provide Most Healthcare The following graph shows that by far most patient/doctor contacts are with GPs.

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Annals of Family Medicine

NOVEMBER 20, 2024

Intervention/Instrument: A research team with the Green Center created the dataset to capture the natural evolution of primary care experiences from 2020 through 2022. Patients said their PCC relationships and trust influenced their vaccine decisions.

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BMJ

AUGUST 20, 2021

In the United Kingdom (UK), primary care practitioners are the first-line clinicians which most patients encounter, providing initial assessment and treatment of a wide variety of conditions. Over one billion prescriptions per year are signed in the UK by these general practitioners (GPs) in primary care.

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FDA Law Blog

AUGUST 14, 2022

The negotiations will result in a Maximum Fair Price (“MFP”) that the manufacturer must make available to providers furnishing the drug under Medicare Part B or pharmacies dispensing the drug under Part D. The same will be required under state Medicaid and CHIP programs by October 1, 2023.

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Medical Xpress

JUNE 8, 2025

The research, published this week in Safety Science , collected data from 562 recreational surfers from 2020 to 2023. million surfs carried out each year in Victoria, researchers estimate that this could equate to more than 70,000 assists and almost 25,500 cases of first-aid provided by surfers annually. times, first aid 0.4

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GeriPal

OCTOBER 31, 2024

Summary Transcript CME Summary In March 2020, we launched our first podcast on COVID-19. My wish was for better randomized evidence for vaccines and treatments, though I worry this might not be feasible. My wish was for better randomized evidence for vaccines and treatments, though I worry this might not be feasible.

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Physician's Weekly

JUNE 26, 2025

Within an hour of receiving a covid vaccination in November 2020, Utah preschool teacher Brianne Dressen felt pins and needles through her arms and legs. While it’s possible that Nath’s patients suffered covid vaccine injuries, Marks said, their symptoms were so varied it was hard to characterize a possible syndrome.

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Vaccination Patient-Centered Government IT 52

GeriPal

JULY 14, 2022

This was the opening paragraph that I wrote in March of 2020 when introducing a podcast we did with Dr. Jim Wright , the medical director at Canterbury Rehabilitation and Healthcare Center in suburban Richmond. That was his literally his life during those spring months of 2020 and it scared the hell out of me. . Darrell: Thank you.

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GeriPal

SEPTEMBER 14, 2023

2020 Hospital at Home-Plus: A Platform of Facility-Based Care. And we would provide ongoing longitudinal care to them in the home, much like the Mount Sinai Visiting Doctors programs, and other programs like that. And the treatments are different than what hospice might provide in the home setting. Annals of Int Med.

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GeriPal

JUNE 2, 2022

We’ve lived through lockdowns, toilet paper shortages, mask mandates, hospital surges where ICU’s overflowed, a million COVID deaths, prolonged school closures, development and roll out of novel vaccines, an explosion of social isolation and loneliness, and the invention of the “zoom meeting.” . Their vaccines aren’t as effective.

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FDA Law Blog

SEPTEMBER 14, 2021

A manufacturer that failed to provide access to the MFP would be subject to a civil monetary penalty of ten times the excessive price charged. The Part B rebate would exclude vaccines as well. PART 2: INFLATION REBATES UNDER MEDICARE PARTS B AND D. PART 4: OIG SAFE HARBOR AMENDMENTS RELATING TO PBM REBATES.

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The Clinical Problem Solvers

DECEMBER 2, 2020

Blame is deflected to populations on the outskirts of society and used as justification to delay or fail to provide aid. 2020, September 20). 2020, May 8). 2020, April 6). 2020, November 12). 2020, November 13). 2020, November 20). 2020, July 7). 2020, April 9). 2020, April 23).

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