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          Botanical Drug Development: Guidance for IndustrySearch for FDA Guidance Documents GUIDANCE DOCUMENT
	Botanical Drug Development: Guidance for Industry
					
		
		December 2016


	Download the  Final Guidance Document
	    
      	      		Read the Federal Register Notice 

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    PrintDocket Number:
		    FDA-2000-D-0103
	    	    		    Issued by:
		    Guidance Issuing Office
          Center for Drug Evaluation and Research


This guidance describes the Center for Drug Evaluation and Research’s (CDER’s) current thinking on appropriate development plans for botanical drugs to be submitted in new drug applications (NDAs) and specific recommendations on submitting investigational new drug applications (INDs) in support of future NDA submissions for botanical drugs. In addition, this guidance provides general information on the over-the-counter (OTC) drug monograph system for botanical drugs. Although this guidance does not intend to provide recommendations specific to botanical drugs to be marketed under biologics license applications (BLAs), many scientific principles described in this guidance may also apply to these products.


 
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						All written comments should be identified with this document's docket number: FDA-2000-D-0103.

                                                                                  Content current as of:
      05/07/2020
         
                  
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