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Shared REMS an Issue for Standardization

By Mari Serebrov
Washington Editor

Friday, July 26, 2013

If the FDA wants innovators to share their risk evaluation and management strategies (REMS) with competitors, it needs to come up with guidance, and possibly incentives, to ensure fair play, a former FDA attorney told the agency Thursday as it kicked off a two-day public meeting on how best to standardize and evaluate REMS.

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