In this episode, Joe interviews Dr. Amanda Holley: pharmacologist and regulatory consultant in nonclinical drug development, and previously a nonclinical pharmacology/toxicology reviewer at the FDA. With Lykos Therapeutics working towards FDA approval of MDMA-assisted psychotherapy for PTSD, ICER (Institute for Clinical and Economic Review) recently published its draft evidence report, concluding that they couldn’t endorse […]

The post An Inside Look at the FDA and Early Drug Development appeared first on Psychedelics Today.

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