The Role of the FDA in Guiding Drug Development

The drug development process is defined here as one that includes the preclinical and clinical phases of drug development following the selection of a lead molecule by the sponsor, and includes the regulatory review phase that is intended to lead to marketing authorization. This process is complex, time-consuming, and costly. A typical new molecular entity (NME), if approved for marketing, has gone through extensive preclinical pharmacology/toxicology evaluation followed by a clinical evaluation stage that lasts, on average, 5–7 years. With an average of 6–10 months required for regulatory review, the entire process, from preclinical evaluation to market approval, may take up to 15 years, with a cost that may exceed $990 million dollars in direct and lost-opportunity costs. Given the current high attrition rate of drugs that enter into clinical testing (~50% in Phase III), the need for more predictive and informative drug development is obvious.