FDA’s New Priority Voucher Pilot Program Has Landed: CNPV
FDA Law Blog: Drug Discovery
JUNE 18, 2025
As described in guidance , the eligibility criteria for RTOR are as follows: Clinical evidence from adequate and well-controlled investigation(s) indicates that the drug may demonstrate substantial improvement on a clinically relevant endpoint(s) over available therapies. Easily interpreted clinical trial endpoints (e.g., months to 5.9.
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