Fast Track, Breakthrough Therapy, Accelerated Approval, Priority Review
Speeding the availability of drugs that treat serious diseases are in everyone's interest, especially when the drugs are the first available treatment or if the drug has advantages over existing treatments. The Food and Drug Administration has developed four distinct and successful approaches to making such drugs available as rapidly as possible:
- Priority Review
- Breakthrough Therapy
- Accelerated Approval
- Fast Track
Because each of these approaches implies speed, there can be confusion about the specific meaning of each and the distinctions among them.