Brands Use Voluntary Restricted Distribution As Much As REMS To Slow Generics

May 17, 2018
FDA's long-awaited list of brand drugs for which generics have sought the agency's help in obtaining the samples necessary for testing and approval confirms that Risk Evaluation and Mitigation Strategies are not the only tool used by brands to withhold samples. While REMS are the most-cited method, over half of the more than 50 drugs on the list unveiled Thursday (May 17) do not have a REMS -- demonstrating the effect so-called voluntary restricted distribution systems are having on generic...

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