Candidates For The US FDA’s STAR Program Might As Well Be Breakthrough Therapies, Too

 
• By Derrick Gingery

The requirements to join the new real-time review pilot program strongly resemble those of the breakthrough designation, which could come as an unpleasant surprise for some sponsors.

FDA website
The FDA's requirements for the STAR program are very similar to the breakthrough therapy designation. • Source: Shutterstock

More from Review Pathways

More from Pathways & Standards