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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New AAM CEO: Traditional Lobbying On Lowering Health Care Costs Can Mix With COVID-19 Talks
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FDA Talks Tough On Complete Response Extensions
The FDA has published fresh guidance taking a tougher stance on sponsor reasons for needing more time to respond to complete response letters.
US FDA Talking Tough On ANDAs, Says Extensions On Complete Responses Need Justification
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.