ANDA User Fee Agreement Expected To Be Finished in Early September
This article was originally published in The Pink Sheet Daily
Executive Summary
FDA wants the commitment letter and draft legislation ready for internal clearance by Sept. 9.
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ANDA Backlog Fee Non-Payment: FDA Will Weigh Fairness Vs. Public Health
FDA may have more than one set of rules to determine whether it will approve a backlogged generic drug if the sponsor does not pay the one-time backlog fee created by the agency/industry agreement on generic drug user fees.