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BioWorld - Thursday, March 28, 2024
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» FDA's oversight of post-approval studies of drugs granted accelerated approval in question
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FDA's oversight of post-approval studies of drugs granted accelerated approval in question
Aug. 21, 2017
By
Nuala Moran
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LONDON – An analysis of 38 post-approval clinical trials ordered by the FDA to provide evidence of efficacy of 22 drugs granted accelerated approval from 2009 to 2013 shows only half of the studies had been completed by April 2017.
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