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Generic Firms Break Camp; FDA Says “First-To-File” Covers Same-Day ANDAs

Executive Summary

FDA's guidance defining "first-to-file" status for generic drug companies launching patent challenges offers some relief for ANDA applicants jockeying for position at the agency - and may offer a further impetus for changes to the current 180-day exclusivity system

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FDA First-Generic Notification Policy May Be Reviewed

FDA will re-examine whether it is legally barred from notifying a generic company early in the ANDA process that it is the first filer eligible for 180-day exclusivity, Chief Counsel Dan Troy said Sept. 30

FDA First-Generic Notification Policy May Be Reviewed

FDA will re-examine whether it is legally barred from notifying a generic company early in the ANDA process that it is the first filer eligible for 180-day exclusivity, Chief Counsel Dan Troy said Sept. 30

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