Noreta Family Medicine
JUNE 25, 2024
The US Healthcare System vs…….South Park ?!?! I have to admit that I’ve never watched an episode of South Park. However, this clip was sent to me by another Direct Primary Care (DPC) doctor, and I thought that it was well done and that it deserved to be shared! Although the medical focus of this video is obesity, I was intrigued by the other highlighted theme – the endless spool of red tape in healthcare.
FDA Law Blog
JUNE 25, 2024
By Sara W. Koblitz — In a short but sweet Guidance issued last week, FDA proposed a dramatic change to the way it evaluates interchangeable biosimilars. For the last 14 years, an applicant could get approval of a biosimilar as a standard biosimilar or an interchangeable biosimilar, but the interchangeable biosimilar presented a higher hurdle to approval: Applicants needed to show that a patient could be switched from the Reference Product to the biosimilar and back without issue.
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