When it comes to finding a path to approval for obesity therapies in the U.S., the Food & Drug Administration has concluded that a Risk Evaluation & Mitigation Strategy is not the answer after all. FDA made that very clear this summer in two very different contexts that involved direct discussion of whether to use the REMS authority in the weight loss class.
The first and most direct decision came when the Food & Drug Administration approved Arena Pharmaceuticals Inc./Eisai Co....