Noreta Family Medicine

APRIL 17, 2024

During our post-medical school residency years, we are trained by many different types of doctors including pediatricians, OB/GYNs, surgeons, psychiatrists, neurologists, ENTs and more. Don’t worry; HIPAA laws protect your privacy and medical information. to your last day on Earth, as I like to say!

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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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FDA Law Blog

SEPTEMBER 10, 2023

In contrast, as the guidance explains, a non-interventional study (also referred to as an observational study) is a type of study in which patients received the marketed drug of interest during routine medical practice and are not assigned to an intervention according to a protocol.

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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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FDA Law Blog

JUNE 7, 2021

FDA also describes how FDA will apply flexibility in applying this standard to different data sets on a case by case basis where either the condition is rare or is serious or there is a great unmet medical need. So how did we get here?

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Clinic IT Private Practice Utilities 98

FDA Law Blog

MAY 3, 2022

Outside of regulators (and, if I do say so, in a much more entertaining way), John Oliver has taken on the spon-con topic several times, including a 2021 episode highlighting issues with local news spon-con and “dicey medical claims.”

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FDA Law Blog

AUGUST 21, 2023

Brand drugs, generic drugs, and medical devices alike have all been the target of state failure-to-warn litigation; in a recent case, OTC acetaminophen is the target. FDA went so far as to issue a proposed rule (see our blog post here ), that ultimately went nowhere.

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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. The preamble notes that this information would help ensure that drugs are being used for approved or otherwise medically accepted indications. Sheldon, v. 42 U.S.C. §§ 1396r-8(k)(3) and 1396r-8(g)(1)(B)(i).

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FDA Law Blog

MAY 15, 2025

He spoke with obvious enthusiasm about the recently announced pilot AI-assisted review and its potential to shave weeks off approval timelines, as he described hearing from one reviewer in the pilot project who said the pilot AI tool completed three days work in gleaning salient facts from medical literature in six minutes.

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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

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). If the drug were legally marketed, the considerations may be different, and therefore CVM recommends that these sponsors “obtain an index listing, approval, or conditional approval.”

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Manufacturing Education Patient-Centered Vaccination 59

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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Family Medicine Initiative

APRIL 10, 2024

Family medicine is neither the most prestigious nor the highest paid medical profession. You no longer need to review all medical records or repeat the whole medical and personal history. Adherence to medical advice improves and unnecessary self-referrals to other doctors decrease. Over time, more trust develops.

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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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FDA Law Blog

AUGUST 14, 2022

Starting July 1, 2023, the IRA will also limit to $35 the total monthly contribution by a Medicare Part B beneficiary for insulin purchased through a durable medical equipment (“DME”) supplier. The same will be required under state Medicaid and CHIP programs by October 1, 2023.

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PEMBlog

APRIL 4, 2024

Be sure to check out our previous posts on: BRONCHIOLITIS , EPIGLOTTITIS , PNEUMONIA , and CROUP The Problem: Free open access medical education (aka FOAM) is great in that it allows for asynchronous, focused learning. For each blog, we extracted information such as author names and date of publication. How can I use these findings?

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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

NOVEMBER 18, 2024

Though he did not mention it, there is also a Medical Device User Fee Act (MDUFA), which accounted for approximately 44% of the budget for the Center for Devices and Radiological Health (CDRH) in FY2023. 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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