Jul 7, 2023 | Comment Letters, FDA
Patients Rising Now submitted comments to the FDA on the recently released guidance on incorporating patient experience data in drug development. In clinical trials, the main areas of focus are the efficacy of a treatment as well as its safety. While these are...
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Feb 14, 2023 | FDA, Featured
Patients Rising Now submitted comments to the Food and Drug Administration (FDA) on making naloxone available as an over-the-counter treatment. Naloxone is a treatment which prevents death in the event of an opioid overdose and is currently only available through...
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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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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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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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