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FDA

Patients Rising Now’s Comments on Oregon’s 1115 Waiver and Impact on Access

Patients Rising Now’s Comments on Oregon’s 1115 Waiver and Impact on Access

Jan 7, 2022 | FDA, Letters Submitted

The FDA’s Accelerated Approval Program provides a path for earlier approval of drugs being developed to treat serious diseases and address unmet medical need. The process allows the use of a surrogate endpoint—an indirect marker of clinical benefit that allows the...
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Letter in support of the nomination of Dr. Robert Califf to serve as Commissioner of the Food and Drug  Administration

Letter in support of the nomination of Dr. Robert Califf to serve as Commissioner of the Food and Drug Administration

Jan 7, 2022 | FDA, Letters Submitted

On behalf of Patients Rising, the organization representing millions of Americans living with chronic disease, I write to support the nomination of Dr. Robert Califf to serve as Commissioner of the Food and Drug Administration. The U.S. Food and Drug Administration...
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Letter in support of the nomination of Dr. Robert Califf to serve as Commissioner of the Food and Drug  Administration

S2 | E30: Pink Socks + Accelerated Approval for Drugs

Aug 9, 2021 | FDA, Featured, ICER, Podcast

On this episode of the podcast, Bob and Kate, filling in for Terry, discuss the attack on Food and Drug Administration accelerated approvals. They point to the recent criticism of the breakthrough Alzheimer’s drug Aduhelm as Exhibit A.  Bob explains how...
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  • PRN and 17 Patient Groups Send Letter to Hill on Home Health Cuts

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