What’s Next? Five Things To Look Out For In October
Mylan And Upjohn Merger May Complete
Executive Summary
In October, the period during which Mylan may complete its merger with Upjohn will begin, while the FDA will begin holding monthly stakeholder meetings ahead of the third iteration of the Generic Drug User Fee Amendments program, also known as GDUFA III.
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The FDA has called on public stakeholders to notify the agency of their participation in the next Generic Drug User Fee Amendments program, as it sets the agenda for improving the generic drug approval process, including for complex generics.