GREY:ATBPF - Post by User
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MasterAlgaeon Nov 29, 2020 8:29am
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Guidence by FDA on Osteoarthritis drugs and Merck paper
Guidence by FDA on Osteoarthritis drugs and Merck paper
The first link was published in June of this year by Merck. Its a good informative read (IMO).
Just to be clear Otenaproxal is a pain drug that seems to work well with arthritis patients (that will likely have much wider applications) - it is not a disease modifying drug.
Quote: "The FDA has acknowledged that OA can be a serious disease, and therapies that can modulate the underlying pathophysiology are required to change the course of the disease and prevent long-term disability."
https://www.sciencedirect.com/science/article/pii/S1359644620301227#bib0040
This second link is recent FDA [application] Guidence titled: Osteoarthritis: structural endpoints for the development of drugs, devices, and biological products for treatment, draft guidance for industry
https://www.fda.gov/media/71132/download