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In 1992, the Food and Drug Administration (FDA) instituted the accelerated approval regulations that allow drugs or biologics for serious conditions that fill an unmet medical need to be approved on the basis of a surrogate endpoint or an intermediate clinical endpoint. The current definition of a s...
November 19, 2018
Journal:
Osteoarthritis Cartilage.
Author:
Kraus VB, Simon LS, Katz JN, Neogi T, Guermazi A, Karsdal MA, Hunter DJ
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