COMP360 could become the first FDA-approved psilocybin therapy. FDA approval would likely trigger a REMS program governing treatment delivery. REMS-certified clinics would operate under federal law, ...
On January 3, 2023, FDA released an updated Risk Evaluation and Mitigation Strategy (REMS) for mifepristone. The updated REMS follows a December 2021 FDA announcement that it would eliminate the ...
Industry and patient groups are asking the US Food and Drug Administration (FDA) to take a flexible approach when reviewing changes that come with switching third-party vendors that provide services ...
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