“FDA User Fees – What Have They Done For You Lately?”
A Webinar Presented by The Weinberg Group
Wednesday, April 25, 2012
12 p.m. (EDT) | 9 a.m. (PDT) | 5 p.m. (GMT)
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.
Please join Marla Scarola, M.S., Senior Consultant, as she discusses:
▪ 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?
This complimentary, one-hour webinar is designed to help life science executives appreciate the value of user fees in an FDA-regulated world.
To join the webinar, please register here. Upon receipt of registration, a dial-in number and log-in information will be sent.