ABSTRACT
This chapter reviews the history of the drug approval process and its evolution in the US In the US prior to 1880 the regulation of drugs and drug marketing was nonexistent or at best a state function. Since the 1930s, drug development has become an industrialized process, with large corporations taking the lead. One often unappreciated aspect of the investigational new drug application/new drug application development process is the amount of data and paper that are generated throughout the process. A key point to realize about the drug approval process is that it is a bureaucracy, in that the final decision regarding approval is not the purview of a single individual but is the collective recommendation of the entire review team. From a drug development standpoint, the need for individualized drug approval packages for the US, Europe, and Japan led to increased costs and was an active disincentive to the approval of some drugs in some countries.
