Generic User Fee Negotiators Struggling To Meet June Deadline
This article was originally published in The Pink Sheet Daily
Executive Summary
FDA does not want to rush, but may consider splitting negotiators into small groups to deal with specific issues.
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Generic Drug User Fees Will Begin With The Backlog
FDA set aside fears that a separate fee for the application backlog would create administrative problems for its generic drug user fee program, instead choosing to use the queue of pending submissions to help gain more funding at launch.