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          Psychedelic Drugs: Considerations for Clinical InvestigationsSearch for FDA Guidance Documents GUIDANCE DOCUMENT
	Psychedelic Drugs: Considerations for Clinical Investigations
					
		
		June 2023


	Download the  Draft  Guidance Document
	    
      	      		Read the Federal Register Notice 

    Draft

	  	    Not for implementation. Contains non-binding recommendations.
	  
	  
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    PrintDocket Number:
		    FDA-2023-D-1987
	    	    		    Issued by:
		    Guidance Issuing Office
          Center for Drug Evaluation and Research


The U.S. Food and Drug Administration (FDA or Agency) is issuing this guidance to provide general considerations to sponsors developing psychedelic drugs for treatment of medical conditions (e.g., psychiatric disorders, substance use disorders). For the purposes of this guidance, the term psychedelic is used as shorthand to include classic psychedelics, typically understood to be 5-HT2 agonists such as psilocybin and lysergic acid diethylamide (LSD), as well as entactogens or empathogens such as methylenedioxymethamphetamine (MDMA).


 
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						All written comments should be identified with this document's docket number: FDA-2023-D-1987.

                                                                                  Content current as of:
      06/26/2023
         
                  
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