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…

Read More