Alzheimer’s Evidence Accelerator Modeled On FDA COVID Project Floated By USAgainstAlzheimer’s
Patient organization exploring development of a multi-stakeholder forum on real world evidence that, among other things, could address research questions posed by the Centers for Medicare and Medicaid Services in its national coverage determination for Alzheimer’s drugs.
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Medicare Registry-Based Studies For Alzheimer’s Drugs Still ‘Challenging’ Prospect – Former CMS Official
Medicare coverage with evidence development requirements for Alzheimer’s drugs that obtain traditional approvals may be more involved than they appear.
Alzheimer's patient groups continue to argue against the CMS draft national coverage determination on Aduhelm, but effort to meet with HHS Secretary Xavier Becerra is thwarted.
After slightly more than two years as second-in-command, Abernethy tells the Pink Sheet she’s leaving FDA because the initiatives on which she was focused were starting to develop their own momentum. Abernethy, who also serves as the agency’s acting chief information officer, worked to modernize the FDA’s information technology infrastructure and data capabilities while also exploring ways to confidently use real-world data to support regulatory decision-making.