UPDATE: Amgen and FDA Agree to Modify Nplate Risk Evaluation and Mitigation Strategy

Amgen

today announced the U.S. Food and Drug Administration has modified the requirements of the Nplate Risk Evaluation and Mitigation Strategy Program. Prescribing physicians, patients and institutions are no longer required to enroll in the safety monitoring program, called the Nplate NEXUS Program, in order to prescribe or receive Nplate.