GDUFA III May Be Opportunity For Proactive Pharmacovigilance Discussions
Executive Summary
Generics sponsors want FDA input before making decisions on pharmacovigilance problems, potentially adding another topic to user fee discussions.
You may also be interested in...
US FDA Investigating Auto-Injector Problems With Copaxone Generics
Reports of bent needles and injector failures also raise questions about the FDA’s complex product approval process.
US FDA Investigating Auto-Injector Problems With Copaxone Generics
Reports of bent needles and injector failures also raise questions about the FDA’s complex product approval process.
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.