FDA is facing questions about whether the growing number of “breakthrough” designations has pulled resources away from other applications, an indication there may be concerns about the demands the program is placing on the agency.
FDA’s Breakthrough Designations Face Question Of Review Resources
Woodcock says FDA will manage breakthrough applications along with its entire portfolio of submissions, but some stakeholders express concern about whether the demands of the exceedingly popular program will affect the agency’s handling of other applications.
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