Drug development approval time frame

Dmgs are chemical compounds that modulate the activity of proteins and other targets associated with a disease state to achieve a desired therapeutic response. The discovery and development of dmgs has traditionally been an inefficient and expensive process. Recent studies have shown that time frames of 10-15 years from the discovery of a validated molecular target to the market introduction of a Food and Dmg Administration (FDA)-approved drug are typical, with the average cost estimated to be in excess of 300 million (1). 

Clinical trials are performed in three stages, which can take from two to six years. After successful completion of the clinical trials, a new drug application (NDA) is submitted to the FDA. The NDA review typically takes two years, after which the NDA is approved. Figure 2 illustrates the time frame for development of a new drug. 

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