FDA’s “breakthrough” designation has been the breakout star of the review changes ushered in under the last user-fee reauthorization. With enthusiastic adoption and positive reviews, stakeholders are eager to replicate the program’s success. The early experience with the breakthrough therapy program could serve as a model for transforming and improving the development and review of drugs and biologic products that do not carry the expedited regulatory pathway designation.
Pharmaceutical and biotechnology sponsors have enthusiastically embraced the breakthrough program. They have swarmed the agency with more than 200 requests...