FDA Law Blog

JANUARY 3, 2024

CVM does not regulate the practice of veterinary medicine (that’s a state licensing board) or vaccines for animal diseases (that’s USDA). Palmer & Riëtte van Laack — Most of us love our furry friends, and with the boom in pet ownership during the pandemic, it is no surprise that the market for pet products has become enormous.

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FDA Law Blog

FEBRUARY 4, 2025

As our readers may already know, FDA maintained three PRV programs to incentivize the development of therapies for underfunded diseases: the RPD PRV program, which sunset last month, the Medical Countermeasures (MCM) PRV Program, which sunset in October 2023, and the Tropical Disease PRV Program.

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FDA Law Blog

JUNE 2, 2023

Kirschenbaum — Last Friday, May 26, CMS published in the Federal Register an assortment of proposals to change the regulations governing the Medicaid Drug Rebate Program. Most are new or revised definitions and administrative changes, but several proposals represent new policies that should be of concern to drug manufacturers. 1396r-8(b)(3)(B).

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FDA Law Blog

AUGUST 21, 2023

Koblitz & Deborah L. Livornese — I saw the sign…and the answer is no—FDA-approved labeling apparently is not enough under state failure-to-warn laws, according to certain courts. Agency officials estimated that it took at least 6 years to complete the required rulemaking process.” More than a few have taken far longer—literally decades.

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FDA Law Blog

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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New South Family Medicine and MedSpa

SEPTEMBER 17, 2019

Then take a moment to reflect on your unique plate. How closely does your current diet and lifestyle reflect the above plate? What similarities do you notice? Whole​ ​wheat​ ​bread,​ ​brown​ ​rice,​ ​and​ ​whole-wheat​ ​pasta​ ​are also​ ​good​ ​sources​ ​of​ ​carbohydrates. Protein has many functions in the body, aside from just giving us energy.

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Physician's Weekly

JUNE 12, 2025

The new members include some vaccine critics. Another RSV antibody called Beyfortus , made by Sanofi and AstraZeneca , was approved in 2023. A vaccine given during pregnancy can also protect newborns, and together, these efforts seem to be working. Merck says the safety of the shot was similar to that of a placebo.

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FDA Law Blog

AUGUST 14, 2022

Inflation rebates under Medicare Parts B and D: Starting in 1Q 2023, mandatory quarterly rebates will be imposed on manufacturers of single-source drugs and biologics covered under Part B that have price increases exceeding the rate of inflation. The same will be required under state Medicaid and CHIP programs by October 1, 2023.

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GeriPal

AUGUST 15, 2024

We discuss: What is considered a hate incident, how is it tracked, what do we know about changes over time The wider impact of Anti-Asian hate on older Asians, who are afraid to go out, leading to anxiety, social isolation, loneliness, decreased exercise, missed appointments and medications. Jessica, welcome back to GeriPal. So here is a little bit.

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GeriPal

APRIL 20, 2023

How has the history of redlining and the federal tax subsidy of wealthy (mostly white) people in the form of a mortgage interest deduction contributed to racial inequalities in homelessness? What can we do about it? What are the highest yield interventions and policy changes? What should we call it – homeless or unhoused? Eric: I love this.

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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. Researchers found that for every 100 surfs, respondents on average gave beachgoers safety advice 11.6 times, first aid 0.4 times and assistance in the water 1.1 This study helps to quantify surfers impact on community safety.

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Family Physicians of Greeley

AUGUST 1, 2023

Vaccines are one of the best ways to keep your child healthy and safe. Did you know that vaccination rates around the country have fallen sharply due to the COVID-19 pandemic? As the summer winds down and we get ready to go back to school, it is important to remember to schedule your child’s back-to-school wellness visit.

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GeriPal

OCTOBER 31, 2024

Our conversation covers: The current state of COVID Evidence for COVID boosters, who should get them, and preferences between Novavax and mRNA vaccines COVID treatments like Molnupiravir and Paxlovid Differences in COVID impact on nursing home residents and those with serious illnesses We wrap up with a “magic wand” question. Is that right?

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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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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. Coverage with Selected Vaccines and Exemption Rates Among Children in Kindergarten — United States, 2023–24 School Year.

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PEMBlog

FEBRUARY 22, 2024

Updated 2023 Jun 26]. They perceive that the intramuscular vitamin k is a vaccine. Furthermore, parents who refuse IM vitamin k tend to refuse other preventative measures, including the Hep B vaccine at birth, prophylaxis against gonococcal ophthalmia, which is really bad, and subsequent routine vaccination.

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GeriPal

SEPTEMBER 14, 2023

In addition to discussing these outcomes, we also discuss: The history of the hospital-at-home movement. The practicalities of how it works including who are good candidates, where does it start (the ED?), what happens at home, do you need a caregiver, what happens if they need something like imaging? How is it financed and what comes next?

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FDA Law Blog

SEPTEMBER 14, 2021

For drugs approved on or before July 1, 2015, the inflation rebates would be payable beginning 3Q 2023, and for those approved after that date, rebates would be payable beginning with the later of 3Q 2023 or the sixth full calendar quarter after launch. The Part B rebate would exclude vaccines as well.

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FDA Law Blog

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.” The first point he made pertained to reforming the Prescription Drug User Fee Act (PDUFA). Andrew J Shattock et al.,

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Physicians News Digest

MARCH 31, 2025

The agency awarded nearly 59,000 grants in fiscal 2023, but the Trump administration has begun canceling hundreds of grants on research topics that new political appointees oppose, including vaccine hesitancy and the health of LGBTQ+ populations. But she never imagined it would be like this. And it doesn’t stop there.

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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. 28, are in states Trump won in November. Kennedy Jr.

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