Generic Priority Review Expanded In Senate User Fee Bill
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.
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Manager's amendment tells US FDA to issue more guidance for complex generics and tells GAO to report on progress towards global harmonization of data standards.
Legislation would create a potential second priority review pathway for generics, as well as another priority review voucher program, but may not be as enticing as GDUFA II proposal.