US FDA Commissioner Scott Gottlieb is keeping a spotlight on the agency's efforts to curb brand company abuses of the Risk Evaluation and Mitigation Strategy (REMS) system that block generic entry.
REMS Barriers: US FDA Takes 'Foundational Step' To Improve Generic Access
Generic firms might be able to purchase branded drugs for bioequivalence studies from Europe under concepts that FDA is considering. Commissioner Gottlieb says FDA may allow generic firms to seek wavier of shared REMS to avoid protracted negotiations.
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The FDA’s accelerated approval draft guidance has left stakeholders seeking clarification of the process for determining a surrogate marker or intermediate clinical endpoint is reasonably likely to confirm clinical benefit.