GDUFA III May Rely Less On PDUFA As A Role Model

06 Jun 2019

Meeting opportunities codified in GDUFA II were adapted from the new drug user fee program experience but may not be well suited to the commodified generic drug industry built on volume and speed, industry representatives said at the recent FDLI annual meeting.

Aerial view container cargo ship, import export business logistic and transportation of International by container ship in the open sea. - Image — Meeting opportunities imported from PDUFA may not be a good fit for the generic drug industry. • Source: Shutterstock

One and a half years into the second iteration of the generic drug user fee program, industry is questioning whether some of the processes adapted from the prescription drug review side are useful in expediting the market availability of generics.

The generic drug sector’s business model and market dynamics are so different from those of the innovator industry that the...