On July 9, 2012 the Food and Drug Administration Safety and Innovation Act (FDASIA) was signed.
FDASIA Section 902 provides for a new designation -. A breakthrough therapy is a drug:
- intended alone or in combination with one or more other drugs to treat a serious or life threatening disease or condition and
- preliminary clinical evidence indicates that the drug may demonstrate substantial improvement over existing therapies on one or more clinically significant endpoints, such as substantial treatment effects observed early in clinical development.