US FDA mulls lowering a REMS hurdle for generic drug makers
This article was originally published in SRA
Executive Summary
The US Food and Drug Administration has signaled its willingness to facilitate efforts by generic drug sponsors to gain access to brand drugs with a risk evaluation and mitigation strategy (REMS)1. However, whether the agency's proposed policy will stop the alleged practice by brand drug companies of using REMS to block competition is questionable.
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