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          FDA Guidance on Conduct of Clinical Trials of Medical Products During the COVID-19 Public Health EmergencySearch for FDA Guidance Documents GUIDANCE DOCUMENT
	FDA Guidance on Conduct of Clinical Trials of Medical Products During the COVID-19 Public Health Emergency
					Guidance for Industry, Investigators, and Institutional Review Boards
		
		August 2021


	Download the  Final Guidance Document 

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    PrintDocket Number:
		    FDA-2020-D-1106-0002
	    	    		    Issued by:
		    Guidance Issuing Office
          Center for Biologics Evaluation and Research
          Center for Devices and Radiological Health
          Center for Drug Evaluation and Research
          Office of the Commissioner, Office of Clinical Policy and Programs, Office of Clinical Policy, Office of Good Clinical Practice


This guidance is intended to remain in effect until November 7, 2023, unless superseded by a revised final guidance before that date.  For further information, refer to 88 FR 15417, March 13, 2023, available at Guidance Documents Related to Coronavirus Disease 2019 (COVID-19).


FDA plays a critical role in protecting the United States from threats such as emerging infectious diseases, including the Coronavirus Disease 2019 (COVID-19) pandemic. FDA is committed to providing timely guidance to support response efforts to this pandemic.

FDA is issuing this guidance to provide general considerations to assist sponsors in assuring the safety of trial participants, maintaining compliance with good clinical practice (GCP), and minimizing risks to trial integrity for the duration of the COVID-19 public health emergency. The appendix to this guidance further explains those general considerations by providing answers to questions that the Agency has received about conducting clinical trials during the COVID-19 public health emergency.


 
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						All written comments should be identified with this document's docket number: FDA-2020-D-1106-0002.

                                                                                  Content current as of:
      04/11/2023
         
                  
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