The Prescription Drug User Fee Act (PDUFA)
Prior to 1992, 70% of new medicines were first approved outside of the United States. This changed once Congress passed the Prescription Drug User Fee Act (PDUFA). The primary purpose of this act was to provide funding to help decrease the time required of the FDA’s drug review process.
Read this recent article by Ann Zambrano, Business Development Manager for Pharmaceutical at Oliver Healthcare Packaging. Ann shares more about the history of PDUFA and how, as a supplier, understanding PDUFA is critical to better supporting pharma clients.
Read the full article, here.