Candidates For The US FDA’s STAR Program Might As Well Be Breakthrough Therapies, Too
The requirements to join the new real-time review pilot program strongly resemble those of the breakthrough designation, which could come as an unpleasant surprise for some sponsors.
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Sponsors looking to file applications continue to wait for the new user fees to be announced, as details of the Split Real-Time Application Review (STAR) program, generic drug facility inspection readiness requirement and other changes are revealed.
Virtual meetings proved successful, and could be allowed again when the next round of user fee reauthorization talks convene.
Over the first five years of the regenerative medicine advanced therapy designation, analysis by the Pink Sheet finds the 40% success rate of requests is comparable to the broader breakthrough therapy designation, despite less stringent RMAT criteria.