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.
Key Takeaways
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A proposal to set different payment levels for accelerated approval drugs is slowing amid more conversations between CMS and the FDA on whether it is...
The FDA has “indicated that new authority potentially may suggest the need for further examination” of the proposed Accelerated Clinical Evidence model, Center for Medicare and Medicaid Innovation Director Elizabeth...
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