FDA Pharmaceutical Approval Process

The process of drug discovery and resulting time to market ranges between 12-20 years and typically costs >$1.2 billion dollars. Although the focus of the Alfred Mann Institutes is primarily in medical device development, there is also some involvement in development of a small number of pharmaceutical compounds. Since only ~.01% of drugs discovered will ever receive FDA approval and the process is very lengthy and arduous, the potential compounds must execute exceptionally robust due diligence before a commitment is extended for them to be pursued in an Alfred Mann Institute.

Drug Discovery and Development: Laboratory-based process of experiments aimed at finding and refining a drug candidate to treat a disease or condition.

Pre-Clinical Trials: Animal studies to determine safety and toxicity.

IND: Investigational New drug Application to the FDA containing results of preclinical studies, results of chemical manufacturing controls (including details of active ingredients, stability and purity) and other laboratory results requesting permission to conduct studies in humans.

NDA: New Drug Application submission to the FDA Center for Drug Evaluation and Research requesting clearance to market the drug contains information on every patient from the clinical trials, and information on the company’s drug production and stocking plan.

Phase 1 Clinical Trials:	20-100 healthy subjects; First-in-man safety studies.
Phase 2 Clinical Trials:	100-500 subjects; Primary focus is efficacy and includes additional safety and side effect analysis. Dosage guidelines formulated.
Phase 3 Clinical Trials:	1,000-5,000 subjects; Pivotal trials. Long-term studies to verify objectives met. Drugs that complete Phase III have ~60% chance of FDA approval. Safety profiles and side effects further studied to determine the benefit-risk relationship.
Phase 4 Clinical Trials:	Ongoing surveillance for side effects in routine use for as long as the drug remains on the market.