Adrian H. B. Gottschalk

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The development of new therapies is a crucial component of efforts to improve healthcare. Because drug development and FDA regulatory review have historically been lengthy and costly processes, the US Congress passed a series of legislative acts, beginning in 1992, known collectively as the Prescription Drug User Fee Acts (PDUFA), which sought to expedite(More)
OPPORTUNITIES FOR IMPROVING THE DRUG DEVELOPMENT PROCESS: RESULTS FROM A SURVEY OF INDUSTRY AND THE FDA In the United States, the Food and Drug Administration (FDA) agency is responsible for regulating the safety and efficacy of biopharmaceutical drug products. Furthermore, the FDA is tasked with speeding new medical innovations to market. These two(More)
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