Analysis of U.S. Food and Drug Administration Draft Guidance on Clinical Trials with Psychedelic Drugs
Healthcare Law Insights blog
JUNE 30, 2023
CGMP recommendations for the manufacture of investigational drug products intended for phase I trials are discussed in the July 2008 guidance “CGMP for Phase 1 Investigational Drugs”. Clinical FDA believes that the characteristics of psychedelic drugs present challenges in designing adequate and well-controlled (AWC) clinical studies.
52 
Let's personalize your content