Abstract
syn. fast track procedure; approval of therapies “that provide a meaningful therapeutic benefit for patients with serious illness” (FDA) will be accelerated; a similar procedure exist in the EC; in this case, approval relies solely or in part on surrogate endpoints for evidence of effectiveness; the average duration for marketing authorisation in the US takes more than 20 months; in an accelerated approval program substances are classified according to their therapeutic potential in P (priority) and S (standard) substances; → see approval, new drug application, surrogate endpoint.
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© 2009 Springer-Verlag/Wien
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Nahler, G. (2009). accelerated approval program. In: Dictionary of Pharmaceutical Medicine. Springer, Vienna. https://doi.org/10.1007/978-3-211-89836-9_7
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DOI: https://doi.org/10.1007/978-3-211-89836-9_7
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