(AGENPARL) – SILVER SPRING ven 16 giugno 2023 GDUFA III includes several enhancements to the ANDA assessment process to maximize the efficiency and utility of each assessment cycle. These enhancements aim to reduce the number of assessment cycles and facilitate timely access to safe, effective, high-quality, and affordable generics.
Fonte/Source: http://www.fda.gov/industry/generic-drug-user-fee-amendments/anda-assessment-program-gdufa-iii-performance-goals-and-program-enhancements