ABSTRACT
Historically, the regulations governing the drug approval process have been driven by health crises. The devastating effects of the elixir of sulfanilamide and thalidomide led to major changes in the way drugs were regulated in the United States. However, as the story of Dr. Wiley’s Poison Squad illustrates, science is now playing a larger role, and initiatives such as the International Conference on Harmonization (ICH) seek to standardize the process worldwide. More recently, economics and the need for timeliness have also played a larger role in the Prescription Drug User Fee Act (PDUFA).
