U.S. New Drug Application & FDA Approvals → Faster Approvals

These faster approval designations allow drugs to come to market more quickly, and drugs can often meet numerous faster approval designations. Drugs approved via one of these routes must undergo continuing post-marketing studies to prove efficacy and safety long-term. The FDA can pull a medication from the market if these ongoing studies show substantial risk or low efficacy in ‘real-world’ patients/situations.