
In July of 2012, a provision in the newly ratified Food and Drug Administration (FDA) Safety and Innovation Act (FDASIA), paved the way for the FDA to further assist drug manufacturers in expediting the development and introduction of new drugs demonstrating early signs of advancement in the treatment of key conditions. Known as the “breakthrough therapy” designation, this new tool is seen by many as yet another positive sign that the FDA is committed to ensuring that innovative drug products are brought to market even more quickly for the millions of patients with serious medical conditions, desperately in need of new therapeutic options.



