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The 21st century cures act (“cures” or the “act”) significantly impacts fda’s review and approval of medical devices, and how medical devices are covered and paid for. Expunges certain records related to psilocybin possession.
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Summarizing The 21st Century Cures Act , Fda issued a proposed rule on november 15, 2018 titled institutional review board waiver or alteration of informed consent for minimal risk clinical investigations. this draft guidance,.
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