Generic Drug Competition Measures Omitted From Year-End Bill

By Beth Wang / December 21, 2022 at 1:46 PM
Congress’ highly anticipated year-end spending package, unveiled Tuesday (Dec. 20), does not include several key measures to boost generic drug approvals and competition, including those that would allow FDA to share brand-drug ingredient information with generic sponsors and curb “parking” of exclusivity by first-to-file generic drug makers, and strengthen FDA’s ability to reject citizen petitions aimed at delaying the approval of generic competition. Those measures were included in House and Senate versions of FDA user fee bills earlier this year,...

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