Drug Discovery and Development Process

Abstract

The complexity in drug development has increased manifolds over the past 40 years, requiring preclinical testing, investigational new drug (IND) applications, and completed clinical testing before marketing approval from the FDA. Generally, new drug applications (NDAs) or biologics license applications (BLA) are reviewed comprehensively before approval, and then drug performance is resubmitted to regulatory agencies for post-marketing studies. The overarching goal is to bring more efficient and safer treatments to the patients as quickly as possible after a thorough medical evaluation.