Pink Sheet - News And Expert Analysis On Pharma Policy And Regulation since 1939

The Centers for Medicare and Medicaid Services is considering imposing price inflation rebates on Part B drugs furnished to enrollees in Medicare Advantage plans in addition to those covered by fee-for-service Medicare.

In an interview with the Pink Sheet, Troy Tazbaz, director of the US FDA's Digital Health Center of Excellence, says the agency lacks authority to regulate assurance labs, which would be used to help AI developers ensure their models are working correctly before submitting them for approval.

Pink Sheet spoke with leaders of a new consortium that hopes to make drug company-patient advocacy group partnerships more efficient and effective.

EU policymakers have the chance to adopt legislation that establishes a strong and predictable framework of incentives for R&D into new medicines, particularly those that require riskier investments, says CSL Behring’s Lutz Bonacker.