GDUFA II? Mylan Lawyer Questions User Fee Law’s Future Absent FDA Progress

A veteran generic drug industry lawyer questioned whether there would, or should, be a second iteration of the Generic Drug User Fee Act on the same day that FDA announced the first public meeting related to GDUFA II.

At the Food and Drug Law Institute’s annual meeting in Washington, D.C. April 20, Mylan NV exec Carmen Shepard...