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Tag Archives: Koseisho

FDA Needs Radical Reform

Posted on April 12, 2017 by Harald — 2 Comments ↓

The nomination of Dr. Scott Gottlieb for FDA commissioner, a political appointee, has created the usual bipartisan furor. He is called unqualified, a renegade, not committed enough to FDA orthodoxy, an industry darling by some and a maverick by others. All Continue reading FDA Needs Radical Reform→

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Posted in The News, The Viewpoint | Tagged ABECB, ABOM, ABS, acute otitis media, antibiotic blog, Bayesian statistics, bronchitis, CABP, CABP Guidance, CRO, delta, EMA, enrollment criteria for CABP, enrollment X-US, FDA, FDA commissioner, Harald Reinhart, Koseisho, M1, M2, non-inferiority margin, placebo-controlled trials, PMDA, Scott Gottlieb, sinusitis | 2 Replies

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