The Direct Doctors Difference

OCTOBER 21, 2021

As an update to that blog , we want to begin by highlighting again that according to Merritt Hawkins, the average wait time for a new patient appointment with a primary care doctor is 29 days, up 50% from 2014. Unfortunately, this problem seems to have worsened acutely with the COVID epidemic.

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Altitude Family & Internal Medicine

OCTOBER 10, 2023

Altitude Family & Internal Medicine (303) 730-2167 COVID-19: Fall and Winter 2023 Update COVID Fall and Winter 2023 Update Thanks for watching our latest COVID-19 Update. In this webinar, Dr. Hansen discusses: If you have enjoyed this webinar, next you may want to.

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East Cary Family Physicians

AUGUST 24, 2023

In this blog, we’ll explore the vital role of sports physicals in preparing your young athletes for a successful and injury-free school year. As your trusted family physicians, we understand the significance of ensuring your child’s health and safety before they dive into the world of school sports and physical activities.

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FDA Law Blog

OCTOBER 24, 2024

Gibbs — A recent blog post focused on the potentially negative implications of the proposed Patent Eligibility Restoration Act (PERA) for manufacturers of generic drugs and biosimilar products. They argued that the legislation was necessary to spur innovation of new vaccines and therapies in response to emerging health threats.

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Noreta Family Medicine

APRIL 17, 2024

There are lab tests, imaging studies, vaccines, and screening questions for people in different age groups, as well as for folks with certain lifestyle habits. The role of an urgent care offices is to help you through an urgent issue; it does not play a role in helping you stay healthy.

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FDA Law Blog

DECEMBER 3, 2023

covered insulin product or vaccine). Applicable Discounts: The manufacturer discounts apply regardless of whether the enrollee is entitled to low-income subsidies (LIS) that pays their deductible, has an enhanced benefit plan with a reduced or no deductible, or uses a drug that is not subject to the deductible (e.g.,

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FDA Law Blog

SEPTEMBER 10, 2023

The COVID-19 vaccines were initially authorized under EUAs, but their approvals do not appear to have been based on RWE. EUAs can, of course, be issued for new uses of approved products, but they do not have to be. Does this offer the potential to use RWE for an initial approval?

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FDA Law Blog

JUNE 7, 2021

From PPE to diagnostics, treatments to vaccines, the review staff have been applying a new statutory standard: that which supports Emergency Use Authorization (EUA) of a product for COVID. So how did we get here? There is no question the last year has been unlike any other for all of us, but FDA has been steeped in “new” too.

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Aspiring Minority Doctor

FEBRUARY 10, 2021

If you've been following my blog over the years, then you already know January is my favorite month. Fully vaccinated with new hair to match As for the getting the vaccine, I received my first dose on December 23rd and my second and final dose on January 9th. Yeah, that didn't happen. Because it's my birthday month!

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FDA Law Blog

JUNE 2, 2023

Best Price Stacking We previously blogged about the 4 th Circuit Court of Appeals decision in United States Ex Rel. Vaccine”: Because vaccines are excluded from the MDRP, CMS proposes to define them solely for purposes of the MDRP. Sheldon, v.

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FDA Law Blog

JUNE 4, 2025

There are also drugs the Assessment identifies as being used off-label without high-quality evidence or for uses that are approved but without rigorous true placebo-controlled trials (namely vaccines) and/or with known safety concerns. We will continue to monitor these developments as they come.

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FDA Law Blog

SEPTEMBER 30, 2024

Another rejected proposal was a definition of “vaccine” (vaccines are exempt from Medicaid rebates), which would have limited this term to a product that is administered prophylactically – i.e., to prevent rather than treat a disease.

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FDA Law Blog

AUGUST 21, 2023

FDA went so far as to issue a proposed rule (see our blog post here ), that ultimately went nowhere. Liability is precisely why the vaccine market shrunk so significantly in the 1980s, going from 26 manufacturers to 4, after lawsuits claiming $3.5 billion in damages were brought between 1980 and 1986.

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FDA Law Blog

MAY 15, 2025

He also promised a clearer vaccine framework from CBER perhaps in a matter of days, a stronger commitment to the letter and the spirit of Right to Try, and major investment in post-market safety surveillance via big data.

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FDA Law Blog

JANUARY 7, 2024

This review was limited to drugs with approved New Drug Applications (NDAs); biologics and vaccines were excluded. Additionally, this review excluded pharmacokinetic and animal studies. In that ten-year period, there were 67 drugs approved with a requirement to conduct a postmarketing pregnancy study, and 99 studies.

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FDA Law Blog

FEBRUARY 4, 2025

Our colleagues have recently blogged about the RPD PRV here and here , its four-year sunset date, and the political drama that it frequently gets caught in. This time, however, the program, which has helped incentivize the development of dozens of pediatric rare disease therapies since 2012, was not renewed.

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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).

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FDA Law Blog

MAY 3, 2022

FDA has issued Untitled Letters for segments on the Balancing Act ranging from a flu vaccine , to a treatment for iron deficiency anemia , as well as one for multiple sclerosis. In the case of prescription drug segments (and in the case of the Duobrii segment), companies typically submit storyboards and scripts to FDA on Form 2253.

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Family Medicine Initiative

APRIL 10, 2024

A recent study of almost 3 million US patients showed that those who visited primary care were much more likely to receive preventive services : 127% more vaccinations, 122% more colonoscopies, and 75% more mammograms. GPs Prioritize Prevention One reason why GPs can improve health and save costs is their stronger focus on prevention.

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FDA Law Blog

JUNE 12, 2024

We are looking forward to seeing the START pilot program chart a path for a broader application of this more enhanced communication approach and FDA’s continued collaboration to facilitate development of new drugs for rare diseases, as we know there are many programs that would benefit from this approach, not just those included in the pilot.

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East Cary Family Physicians

OCTOBER 9, 2023

In this blog, East Cary Family Physicians explores the critical importance of fall shots, focusing on Respiratory Syncytial Virus (RSV), COVID-19, and the seasonal flu. Let’s delve into why fall is the perfect time to prioritize these vaccines and understand how they can safeguard your family’s health.

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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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FDA Law Blog

JANUARY 29, 2025

Aside from his many high profile claims about vaccines, what he perceives as corruption at FDA, and his promise to go wild on health, Kennedys specific policy preferences about how FDA should administer its day-to-day oversight of drugs, medical devices, food, dietary supplements, cosmetics, or tobacco have not been publicly detailed.

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Family Physicians of Cedar Rapids

JUNE 13, 2025

thanks to vaccines but with declining vaccination rates, it’s made a comeback. How to Keep Your Family Protected Check those vaccines. The MMR vaccine (measles, mumps, rubella) is safe, effective, and usually given in two doses, one at 12-15 months, and another at 4-6 years. It was nearly eliminated in the U.S.

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Evergreen Family Medicine

MARCH 3, 2025

So, to ensure the high-risk groups get vaccinated, it was necessary to recommend it for everybody.Dr. Fauci replied that the correct action was to target high-risk groups. However, this becomes a nuanced message that the public may not understand. Fauci was willing to sacrifice truth for the sake of mess

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FDA Law Blog

AUGUST 14, 2022

Vaccines: Starting in 2023, Medicare Part D will cover all adult vaccines approved by the Advisory Committee on Immunization Practices (“ACIP”) without any deductible or coinsurance. The same will be required under state Medicaid and CHIP programs by October 1, 2023.

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PEMBlog

APRIL 4, 2024

After searching 177 keywords using FOAMSearch, the top 50 FOAM websites on the (now defunct) Social Media Index, and seven additional PEM-focused blogs, we reviewed and quality assessed 441 blog posts on relevant topics. For each blog, we extracted information such as author names and date of publication. Happy learning!

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PEMBlog

JANUARY 17, 2024

And so a lot of the previous studies on getting blood cultures were done in the immediate post Haemophilus influenzae B and Prevnar vaccine era. Vaccinate your children, people. I’ll take a comment on the blog. And we do now live in an era where these invasive organisms are fortunately not as big of a concern.

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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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FDA Law Blog

SEPTEMBER 14, 2021

The Part B rebate would exclude vaccines as well. Excluded from both the Part B and the Part D rebates would be drugs in shortage, drugs subject to an MFP (see Part 1, above), and drugs for which the average total annual allowed charges (Part B) or cost (Part D) for an individual are less than $100 (adjusted for inflation after 2023).

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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.” 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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PEMBlog

MAY 9, 2024

Common variants associated with general and MMR vaccine-related febrile seizures. Vaccines don’t cause autism, but they might cause febrile seizures. The absolute risk is small, and genetic susceptibility likely plays a role in seizures after vaccines. In: StatPearls [Internet]. Nat Genet 2014; 46:1274.

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