Pharmaceutical Development

Drug development has become exponentially more difficult over the last 40 years; it now requires preclinical studies, investigational new drug (IND) filings, and full clinical testing before receiving FDA marketing clearance. In general, new drug applications (NDAs) and biologics license applications (BLAs) are thoroughly evaluated before approval and then resubmitted to regulatory authorities for post-marketing research. The ultimate objective is to provide patients with more effective and safer therapies as quickly as possible after a complete medical review. There are 5 essential milestones (phases) in the drug development process in the United States, each having stages within it. We will explore each of these phases and stages in detail to fully grasp the whole process. Phase 1: Discovery and Development New drugs are discovered through drug discovery. Since the sequencing of human DNA was implemented, reverse pharmacology has identified cures for existing ailments. Researchers th...