FDA Law

SEPTEMBER 30, 2024

Gaulkin — In May 2023, we posted about a CMS proposed regulation that sought to make a wide variety of changes to the Medicaid Drug Rebate Program (MDRP), including a new “price verification survey,” and a controversial proposal to require “stacking” of discounts to different customers when determining best price. Kirschenbaum & Sophia R.

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FDA Law

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

APRIL 7, 2025

Zenrelia comes with serious warnings, including a boxed warning against the use of Zenrelia during vaccination. CVM also objected to the truncation of other information about the timing of vaccines in these promotional materials. Zenrelia promotional materials also included claims about clinical data that the Agency found actionable.

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Physician's Weekly

JUNE 12, 2025

In a clinical trial, Enflonsia cut RSV-related hospital stays in infants by more than 84% compared to a placebo. The new members include some vaccine critics. Another RSV antibody called Beyfortus , made by Sanofi and AstraZeneca , was approved in 2023. Health and Human Services Secretary Robert F. Kennedy Jr.

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GeriPal

AUGUST 15, 2024

We could wear masks against Covid, but we couldn’t vaccinate against racism. Really, across the board, there was a spike, and it seemed to have, seems to have come down from 2022 to 2023. We do a lot of clinical focused discussions. But if I were in the PCP setting or clinic, again, I would definitely use it.

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GeriPal

APRIL 20, 2023

I would talk about this, except I was a clinician, and I’m seeing these folks in the hospital and in clinic. The journal section’s requirements are the same as for a clinical investigation. In the United States in 2023, the truth of the matter is you don’t need very many individual risk factors to become homeless.

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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. His clinical study was ending. But for Dressen and others convinced the vaccines injured them, their experiences were symptomatic of a well-intentioned but flawed U.S.

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PEMBlog

APRIL 4, 2025

The episode emphasizes thoughtful, individualized care in the context of rising vaccine hesitancy and declining immunization rates. Changing epidemiology of outpatient bacteremia in 3- to 36-month-old children after the introduction of the heptavalent-conjugated pneumococcal vaccine. Immunized means that you have no vaccines.

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PEMBlog

DECEMBER 4, 2024

In this episode of PEM Currents: The Pediatric Emergency Medicine Podcast , we explore pertussis, also known as whooping cough – a disease that remains a public health challenge despite widespread vaccination efforts. Pertussis infection in infants and children: Clinical features and diagnosis. link] UpToDate Yeh S et al.

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GeriPal

SEPTEMBER 14, 2023

That’s focused on older adults who are too frail to get into clinic. In that clinical experience, we saw a lot of older adults who would develop acute illness, often exacerbations of their chronic conditions. We relied on our clinical experience as geriatricians, that home-based primary care experience. Bruce: Sure.

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FDA Law

NOVEMBER 18, 2024

Referencing an interview with Kennedy from 2023, the Post says that his views on health “were a head-scratching spaghetti of what we can only call warped conspiracy theories, and not just on vaccines.” He has equated vaccination to the Holocaust and argued that COVID-19 was “ethnically targeted” to spare Ashkenazi Jews and the Chinese.

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Physicians News Digest

APRIL 17, 2025

The Trump administration has canceled hundreds of grants supporting research on topics such as vaccination; diversity, equity, and inclusion; and the health of LGBTQ+ populations. Others followed the Senate confirmation of anti-vaccine activist Robert F. Kennedy Jr. Thank you for public service. NIH grants routinely span several years.

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