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REMS Barriers: US FDA Takes 'Foundational Step' To Improve Generic Access

Executive Summary

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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Disease-Specific Drug Development Guidances Coming From US FDA In 2018

Alzheimer's disease, amyotrophic lateral sclerosis, migraine, and opioid dependence are among conditions that will get drug development guides from FDA; other guidances will address ANDA bioequivalence studies, shared REMS, and continuous manufacturing.

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