Breakthrough-Style Program For ANDAs Added To House User Fee Bill
Energy and Commerce subcommittee unanimously advances reauthorization legislation with four added amendments, including one that would allow for certain generic sponsors to meet early and often with FDA to speed development.
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Amendment added during markup would require eight-month review of ANDAs for shortage drugs and those with limited competition, as well as pre-submission meetings.
Omnibus legislation to fund the federal government for FY 2017 includes an increase in non-user fee funds, which should please stakeholders.
Sen. Leahy's reintroduced CREATES Act allows generic sponsors to sue innovators who fail to provide sufficient quantities of REMS covered products, but seems to give wide latitude to courts; bill reflects Congress' broader focus on generic drugs to address drug pricing issue.