FDA user fees have been fact of life for regulated industry for nearly two decades. As you continue to comply by paying the fees, you should understand what the revenue does for you. This webinar will provide a history of the Prescription Drug User Fee Act (PDUFA) from its inception to its latest reauthorization (PDUFA V). We will discuss the various PDUFA mandates that FDA has described over the years and how well the Agency is doing in achieving their PDUFA goals. We will also cover the pending Generic Drug User Fee Act (GDUFA) and the potential impact it may have on the industry.
Marla Scarola, M.S., Senior Consultant, discussed the following topics:
- Remembering a pre-PDUFA world
- History of PDUFA and achievements to date
- Goals of PDUFA V
- What is GDUFA and what are its potential benefits?