ANDA Sponsors Get Some Relief on New Stability Requirements
This article was originally published in The Gold Sheet
FDA still expects rush of ANDA submissions before new stability requirements take effect June 20, but agency has eliminated some tests and reduced some batch sizes in response to industry comments.
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The agency advises sponsors to follow the stability testing recommendations in the International Conference on Harmonization guidances; three companies submit comments seeking clarification from FDA.
The agency was expecting many pending generic drug submissions to be withdrawn because sponsors would not want to pay the one-time backlog fee, but instead saw a substantial increase near the end of FY 2012.
With inspectors no longer out in the field, they have more time to wrap up work on previously completed facility evaluations, attorney Howard Sklamberg says; inspections freeze could delay manufacturers’ abilities to bring facilities into compliance following adverse inspection findings, as well as agency reclassifications of facility status.