Tagged as: REMS

APPEAL FOR LEGISLATIVE ACTION TO ADDRESS REMS CONCERNS

Last month, during the Biosimilar and Generics User Fee Acts (BsUFA II and GDUFA II) reauthorization hearing, a subject of considerable discussion was Risk Evaluation and Mitigation Strategies (REMS). REMS is a provision under the Food and Drug Administration Amendments Act (FDAAA), which was enacted in 2007, that provides the FDA with…

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