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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Apr 9, 2022 | Access, Featured
WASHINGTON — Patients Rising Now Executive Director Terry Wilcox today released the following statement in response to CMS’ final decision to restrict access to FDA-approved Alzheimer’s treatments to clinical trial participants: “It’s a sad day for the millions...
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Jul 22, 2021 | Federal Issues
FDA Must Step Up Oversight of Hand Sanitizer Safety By Marlene Wüst Smith, MD Hand sanitizer – it’s the go-to item for protecting our kids, even our “big” kids, those attending college in person. We keep it in our cars, our briefcases, kids’ backpacks, and our...
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Jun 27, 2021 | Featured, Federal Issues, Podcast
On this episode of the podcast, Terry and Bob discuss the FDA’s advisory committees, which help the agency decide how to make its approval decisions. Three committee members recently resigned following the FDA’s approval of Aduhelm, the first new...
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