Breakthrough designation


Rescinding Breakthrough Therapy Designation – Guidance Provides FDA’s Thinking

The breakthrough therapy designation (BTD), once awarded to a drug product under development, triggers a rather intensive use of Agency resources, such as providing “early and frequent advice, conduct multidisciplinary meetings involving senior managers, and when appropriate, expedite the review of resultant marketing applications.”  The program is designed to “facilitate and expedite” review of promising […]

Read More