Generic Association’s New CEO Signals Focus On Communications
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.
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The FDA has published fresh guidance taking a tougher stance on sponsor reasons for needing more time to respond to complete response letters.
But most generic sponsors already give reasons for needing more time to respond to a complete response letters, so the status quo may not change despite the new guidance.
Talks between US FDA and industry to extend the generic drug and prescription drug user fee programs may last into 2021.