Source JD Supra https://www.jdsupra.com/legalnews/new-fda-guidance-on-psychedelic-drug-4106424/ Stephanie Agu, David Fox, Lynn Mehler Hogan Lovells   On Friday, the U.S. Food and Drug Administration (FDA) published the draft guidance “Psychedelic Drugs: Considerations for Clinical Investigations,” which outlines the foundational constructs for investigating the therapeutic potential of these compounds. Below we summarize these special considerations for clinical studies of psychedelic drugs, including CMC 

​ Source JD Supra https://www.jdsupra.com/legalnews/new-fda-guidance-on-psychedelic-drug-4106424/ Stephanie Agu, David Fox, Lynn Mehler Hogan Lovells   On Friday, the U.S. Food and Drug Administration (FDA) published the draft guidance “Psychedelic Drugs: Considerations for Clinical Investigations,” which outlines the foundational constructs for investigating the therapeutic potential of these compounds. Below we summarize these special considerations for clinical studies of psychedelic drugs, including CMC […] 

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