(AGENPARL) – SILVER SPRING lun 17 aprile 2023 FDA is establishing a Rare Disease Endpoint Advancement (RDEA) Pilot Program to support novel efficacy endpoint development for drugs that treat rare diseases. The RDEA Pilot Program fulfills a commitment under PDUFA VII
Fonte/Source: http://www.fda.gov/drugs/development-resources/rare-disease-endpoint-advancement-pilot-program