2012 Clinic IT Provider 
Noreta Family Medicine
FEBRUARY 12, 2025
An Escape Fire for Healthcare I recently watched a film, called “ Escape Fire: The Fight to Rescue American Healthcare, ” a 2012 documentary about how the priorities in the US healthcare system are focused on increasing revenue, instead of on goals that improve health, like preventive care.
FDA Law Blog
MAY 13, 2024
FDA has even gone so far as to maintain that the “real-life clinical performance of a medical product might be more clearly demonstrated through RWD/RWE because a controlled clinical trial often cannot evaluate all applications of a product in clinical practice across the full range of potential users.”
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FDA Law Blog
JANUARY 12, 2025
Sasinowski On December 5, 2024, FDA published a new draft guidance on accelerated approval providing a much needed and substantial update to its guidance on the pathway. an intermediate clinical endpoint) and that is reasonably likely to predict an effect on irreversible morbidity or mortality or other clinical benefit.
PEMBlog
MAY 1, 2025
In this episode, we tackle the clinical mischief of Parvovirus B19 , a common viral infection with a surprisingly wide range of manifestationsfrom the classic slapped cheek rash of erythema infectiosum to aplastic crises in children with hemolytic anemias and fetal hydrops in pregnant contacts. UpToDate , Jun. link] Edwards, Morven S.
FDA Law Blog
JUNE 29, 2022
Breakthrough Therapy Designation (BTD) was created in 2012 as part of the FDA Safety & Innovation Act (FDASIA). Subsequently, CDER, in MAPP 6025.6 , and CBER, in SOPP 8212 , provided more granularity as to how this process would work with step-by-step instructions for FDA staff.
FDA Law Blog
FEBRUARY 29, 2024
A surrogate endpoint is a marker, such as a laboratory measurement, radiographic image, physical sign or other measure that is thought to predict clinical benefit but is not itself a measure of clinical benefit. Drug companies are still required to conduct studies to confirm the anticipated clinical benefit. That did not happen.
FDA Law Blog
AUGUST 18, 2024
The De Novo process provides a regulatory pathway to classify novel devices for which general controls alone or general and special controls provide reasonable assurance of safety and effectiveness for the intended use. Each of these De Novos can represent a clinical advance. These legislative changes helped.
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