The US Medicare agency is reconsidering a proposal to set differential payment levels for accelerated approval drugs based on continued dialog with the US Food and Drug Administration about whether the agency’s newly enhanced AA authorities will ensure confirmatory trials are completed in a timely fashion.
US Medicare Agency Reconsidering Proposed Accelerated Approval Payment Demo
The US Medicare agency is not moving forward with a proposal to cut payments for drugs with accelerated approval status pending further discussions with the FDA about whether new regulatory authorities have addressed concerns about timely completion of confirmatory trials.
