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)
without whose encouragement this project would not have been possible. We also thank the interviewees in industry, academia and the FDA who generously gave of their time to meet with us. Responsibility for any errors and opinions expressed herein rests solely with the authors. In the United States, the Food and Drug Administration (FDA) agency is(More)
to Berndt and Gottschalk from general funds at the Harvard-MIT Division of Health Sciences and Technology is gratefully acknowledged. We thank Ed Hass of the FDA and Roy Gross of MIT for their very significant assistance throughout this project. The views and opinions expressed in this paper are those of the authors, and do not necessarily reflect any(More)
Sciences and Technology is gratefully acknowledged. We thank Ed Hass of the FDA and Roy Gross of MIT for their very significant assistance throughout this project. The views and opinions expressed in this paper are those of the authors, and do not necessarily reflect any official positions or policies of the institutions or companies with which they are or(More)
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