
(AGENPARL) – SILVER SPRING lun 24 aprile 2023 The Prescription Drug User Fee Act (PDUFA) was created by Congress in 1992 and authorizes FDA to collect fees from companies that produce certain human drug and biological products. Since the passage of PDUFA, user fees have played an important role in expediting the drug approval process.
Fonte/Source: http://www.fda.gov/industry/fda-user-fee-programs/prescription-drug-user-fee-amendments