Graphic of Regulatory Science sample map
There is no standard route through which drugs are developed. A pharmaceutical company may decide to develop a new drug aimed at a specific disease or medical condition. Sometimes, scientists choose to pursue an interesting or promising line of research. In other cases, new findings from university, government, or other laboratories may point the way for drug companies to follow with their own research.

The new drug development is a very costly process. The fully capitalized cost to develop a new biotechnology drug, including studies conducted after receiving regulatory approval, averages $1.2 billion, according to an analysis by the Tufts Center for the Study of Drug Development (2006). Notably, only five in 5,000 compounds that enter preclinical testing make it to human testing, and only one of the five tested in human is approved by the Food & Drug Administration (FDA).

The average time for the FDA to approve new drugs declined to 1.1 years in the 2005-07 period, but longer average clinical phase time means combined clinical and approval time continues to hover around eight years.

New Drug development process can be divided into 4 phases:

  • Drug discovery and basic research
  • Pre-clinical development
  • Clinical trial
  • FDA filing and post approval