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First-cycle approvals took longer than multi-cycle approvals in the generic drug user fee program's first year, but decreased dramatically in year two.
Application for an acne medication is first to be approved with a formal review goal under GDUFA, and comes five months early.
The Dealmaking column is a survey of recent transactions, including strategic alliances, mergers & acquisitions, and financings, in the life sciences industries. Deals are listed by the following industry sectors: in vitro diagnostics, medical devices, pharmaceuticals, and research/analytical instrumentation and reagents. All transactions are excerpted from Elsevier's Strategic Transactions database, providing comprehensive transaction coverage from 1991 to the present.
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