Reactivation Fee Is Proposed For Biosimilar INDs Placed On Hold
This article was originally published in The Pink Sheet Daily
Executive Summary
Idea could save sponsors from paying annual fees for INDs that are shelved during development.
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Generic Drug User Fees Will Begin With The Backlog
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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.