Generics Bid the User Fee-free Era Farewell
Under the Generic Drug User Fee Amendments of 2012 (GDUFA), generic drug manufacturers now pay fees to offset Food and Drug Administration (FDA) expenses incurred when reviewing applications and inspecting manufacturing and other facilities. Meg Egan Auderset at Thomson Reuters discusses how the GDUFA programme is meant to mitigate FDA costs while reducing both approval times and the backlog.
http://jforcs.com/jcs/wp-content/uploads/edd/2012/11/1-Generics-Bid-the-User-Fee-free-Era-Farewell.pdf