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Home » Shared REMS Requirement Puts Innovators in Anti-Trust Crosshairs, Drugmaker Says
Shared REMS Requirement Puts Innovators in Anti-Trust Crosshairs, Drugmaker Says
June 4, 2013
No other federal law requires one party to work as a business partner with its direct competitor, brand drugmaker Prometheus complains in a citizen petition, calling the FDA’s requirement that innovators share a single risk management plan with their generic competitors “unprecedented.”