Adrian H. B. Gottschalk

Learn 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)
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)
  • 1