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          Postmarketing Adverse Event Reporting for Medical Products and Dietary Supplements During a PandemicSearch for FDA Guidance Documents GUIDANCE DOCUMENT
	Postmarketing Adverse Event Reporting for Medical Products and Dietary Supplements During a Pandemic
					
		
		May 2020


	Download the  Final Guidance Document
	    
      	      		Read the Federal Register Notice 

    Final

	  
	  
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    PrintDocket Number:
		    FDA-2008-D-0610
	    	    		    Issued by:
		    Guidance Issuing Office
          Center for Food Safety and Applied Nutrition
          Center for Drug Evaluation and Research
          Center for Devices and Radiological Health
          Center for Biologics Evaluation and Research


This guidance provides recommendations to industry regarding postmarketing adverse event reporting for drugs, biologics, medical devices, combination products, and dietary supplements during a pandemic. FDA anticipates that during a pandemic, industry and FDA workforces may be reduced because of high employee absenteeism while reporting of adverse events related to widespread use of medical products indicated for the treatment or prevention of the pathogen causing the pandemic may increase. The extent of these possible changes is unknown. This guidance discusses FDA’s intended approach to enforcement of adverse event reporting requirements for medical products and dietary supplements during a pandemic.




 
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						All written comments should be identified with this document's docket number: FDA-2008-D-0610.

                                                                                  Content current as of:
      05/11/2020
         
                  
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