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          Environmental Assessment of Human Drug and Biologics ApplicationsSearch for FDA Guidance Documents GUIDANCE DOCUMENT
	Environmental Assessment of Human Drug and Biologics Applications
					Guidance for Industry
		
		July 1998


	Download the  Final Guidance Document
	    
      	      		Read the Federal Register Notice 

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    PrintDocket Number:
		    FDA-1998-D-0278
	    	    		    Issued by:
		    Guidance Issuing Office
          Center for Drug Evaluation and Research
          Center for Biologics Evaluation and Research


The National Environmental Policy Act of 1969 (NEPA) requires all Federal agencies to assess the environmental impacts of their actions and to ensure that the interested and affected public is informed of environmental analyses. The Food and Drug Administration (FDA) is required under NEPA to consider the environmental impacts of approving drug and biologics applications as an integral part of its regulatory process. FDA's regulations in 21 CFR part 25 specify that environmental assessments (EAs) must be submitted as part of certain new drug applications (NDAs), abbreviated applications, applications for marketing approval of a biologic product, supplements to such applications, investigational new drug applications (INDs) and for various other actions (see 21 CFR 25.20), unless the action qualifies for categorical exclusion.


 
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						All written comments should be identified with this document's docket number: FDA-1998-D-0278.

                                                                                  Content current as of:
      02/22/2018
         
                  
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