Health affairs (Project Hope)DrugsGenericUnited StatesDrug ApprovalHumans
Impact Of Risk Evaluation And Mitigation Strategies On Generic Approvals Of US Pharmaceutical Products.
Jennifer Kao, Victor L Van de Wiele, Reed F Beall, Ameet Sarpatwari
Published: 202510.1377/hlthaff.2024.01476
Abstract
Risk evaluation and mitigation strategy (REMS) programs help ensure that the benefits of certain high-risk medications outweigh their risks. With the routine use of REMS programs, however, concerns have emerged that they may delay the approval of gen…
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