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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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.
Allergenic extract products, previously excluded, also will become part of the user fee program beginning in FY 2023.