We use cookies to provide you with a better experience. By continuing to browse the site you are agreeing to our use of cookies in accordance with our Cookie Policy.
Accept
Home » FDA Plans to Clarify Criteria on Breakthrough Therapy Designations
FDA Plans to Clarify Criteria on Breakthrough Therapy Designations
SAN DIEGO — Two years after it was launched, the FDA’s breakthrough therapy designation, and what qualifies as a breakthrough, continues to baffle drugmakers who have experienced a roughly 63 percent rejection rate in receiving the expedited designation.