Shared REMS: US FDA Wants Brisk Brand-Generic Talks, Might Give Unilateral Waivers
Executive Summary
New draft guidances are an attempt to curb abuse of REMS single shared system process to delay generic entry.
You may also be interested in...
How Do You Know If A REMS Is Effective? Look At Postmarket Data, Surveys, Patient Access
US FDA draft guidance describes how to determine if a Risk Evaluation and Mitigation Strategy is meeting its goals; another guidance advises how to conduct REMS knowledge surveys.
Lilly CEO Breaks From PhRMA, Innovators With Support For CREATES Act
Legislation that would prevent REMS from blocking generics appears to be gaining momentum.
Lilly CEO Breaks From PhRMA, Innovators With Support For CREATES Act
Legislation that would prevent REMS from blocking generics appears to be gaining momentum.