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Brand Exclusivity 'Gaming' To Be Addressed At US FDA Meeting

Executive Summary

Commissioner Gottlieb outlines several steps agency is taking – including potentially dropping requirement for shared REMS – to create more competitive generic marketplace.

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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. 

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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