My name is Harper Elle Howard and I was born April 12, 2010. My family often times calls me Harperpotamus after the Christmas song, “I want a hippopotamus for Christmas.” My story is only 27 months long but my experiences are many! I have traveled [...]
The Prescription Drug User Fee Act (PDUFA) allows the FDA to collect fees from drug makers that produce specific human drug and biological products. The statutory authority for PDUFA expires in September 2012. At that time, new legislation will be required for FDA to continue collecting user fees for the prescription drug program (the renewal of this Act is called PDUFA V). The FDA will hold the first of many meetings on July 1 to gather input in advance of the next PDUFA, giving stakeholders an opportunity to weigh in on user fees the agency charges for drug review and how those fees are used by the agency.