Analysis of U.S. Food and Drug Administration Draft Guidance on Clinical Trials with Psychedelic Drugs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 investigational drugs intended for phase II and III trials are discussed in the May 2003 guidance “INDs for Phase 2 and 3 Studies; Chemistry, Manufacturing, and Controls Information”. For one, the use of an inert placebo may present a challenge.
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