FDA Invites Stakeholders To Join GDUFA III Talks Virtually
Dan Leonard Has Taken Helm Of AAM Just Ahead Of User Fee Negotiations
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.
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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.
Dan Leonard’s communications background, in addition to his policy expertise, may prove useful for the Association for Accessible Medicines as it navigates ongoing market and public policy challenges.
The FDA has revealed details of its recent warning letter to Shilpa, which cites the company’s failure to adequately investigate out-of-specification results and complaints as well as to follow written procedures for complaint handling.