How Does Accelerated Approval Compare with Breakthrough Therapy Designation?
While both accelerated approval and breakthrough therapy designation aim to expedite the drug approval process, they serve different purposes. Accelerated approval is based on surrogate endpoints and requires post-approval studies. Breakthrough therapy designation, on the other hand, is granted to drugs that show substantial improvement over existing therapies based on preliminary clinical evidence. Drugs with breakthrough designation receive more intensive guidance from the FDA during development but do not necessarily qualify for accelerated approval.
