Introduction to FDA's Psychedelic Drugs:Considerations for Clinical Investigations Guidance for Industry
Objective:To promote the development,research,and regulation of psychedelic drugs for the treatment of psychiatric and psychological disorders in China.Methods:The newly issued relevent guidances were searched on the website of US Food and Drug Administration(FDA),and a detailed and specific introduction to them was provided.Results and Conclusion:The specific content of the FDA's Psychedelic Drugs:Considerations for Clinical Investigations Draft Guidance for Industry issued in June 2023 was presented,which proposes some general considerations for the development of psychedelic drugs for the treatment of psychiatric and psychological disorders(e.g.,psychiatric disorders,substance use disorders)in clinical researches to ensure compliance with ethical requirements,trial integrity,and reliability of results.The guidance discussed the special issues faced in the following professional fields related to psychedelic drugs and clinical research separately:chemistry,manufacturing,and controls;nonclinical trials;cinical pharmacology;abuse potential assessment and clinical trials.This guidance has important reference value for China to carry out work in this area.
US Food and Drug Administration(FDA)psychedelic drugpsychiatric and psychological disorderclinical investigationguidance
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