Home » Goals for Unsolicited Amendments Dominate Recent User Fee Meeting
Goals for Unsolicited Amendments Dominate Recent User Fee Meeting
The generic-drug industry and the FDA have agreed to a three-tier system of review goals for ANDA amendments under the new generic-drug user fee program now under negotiation. Review goals would vary depending on the number and type of amendments companies file, according to minutes from a recent meeting to establish the program.
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