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Home » FDA Loosens Expanded Access Requirements as Gottlieb Testifies on Right-to-Try Bills
FDA Loosens Expanded Access Requirements as Gottlieb Testifies on Right-to-Try Bills
As federal right-to-try legislation gathers steam on Capitol Hill, the FDA rolled out measures to streamline its expanded access process — including loosening institutional review board requirements — and issued new guidance to manufacturers on its use of adverse event data.