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

27 Apr 2015

Generic drug companies will want to see some tangible improvements from agency, including faster ANDA reviews and more approvals, before starting negotiations to reauthorize the user fee law.

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...