Growth In ANDA Submissions Is Leveling Off, OGD Director Says
This article was originally published in The Pink Sheet Daily
Executive SummaryWhile still growing and setting records, change in pace of submissions could give FDA "breather" to work on backlog.
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Association for Accessible Medicines’ interim leader is General Counsel Jeffrey Francer; Chip Davis’ four-and-half year tenure included a total rebrand of the association, a significant legislative victory with the CREATES act – and an abrupt departure for the Healthcare Distribution Alliance.
PDUFA and GDUFA negotiations are expected to begin first, as they usually take the longest to complete, and will be followed by BsUFA talks.