Generic User Fees Must Be Considered Due To Ballooning ANDAs – FDA’s Galson
Executive Summary
The "exponential" growth of ANDA submissions necessitates an examination of user fees for generic applications, Center for Drug Evaluation & Research Director Steven Galson told the Generic Pharmaceutical Association's Fall Technical Conference Oct. 24
You may also be interested in...
FDA Faces Pricing Pressure As Generic Drug User Fee Debate Begins
Emerging discussions on the creation of a user fee program for generic drug review place FDA in the awkward position of potentially being seen as an arbiter of drug prices - at least indirectly
FDA Faces Pricing Pressure As Generic Drug User Fee Debate Begins
Emerging discussions on the creation of a user fee program for generic drug review place FDA in the awkward position of potentially being seen as an arbiter of drug prices - at least indirectly
Citizen Petition Reform Proposals Include User Fees, Payments For Lost Profits
User fees for citizen petitions may discourage abuse of the process, Sandoz VP-Intellectual Property & Regulatory Shashank Upadhye said Sept. 30 at the Institute for International Research's Annual Generic Drugs Summit in Washington, D.C