The FDA approval process for new drugs is a long and rigorous process that can take over a decade to complete. Drugs must pass through pre-clinical, three phases of clinical trials involving both healthy volunteers and patients to test for safety, efficacy and side effects. If the drug is found to be safe and effective through the clinical trials, the company can then file a New Drug Application to the FDA for review, which typically takes 1-2 years. Throughout this highly regulated process, only about 5 out of every 5000 compounds initially discovered will make it to market approval due to safety or efficacy issues.