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          Advancement of Emerging Technology Applications for Pharmaceutical Innovation and Modernization Guidance for IndustrySearch for FDA Guidance Documents GUIDANCE DOCUMENT
	Advancement of Emerging Technology Applications for Pharmaceutical Innovation and Modernization Guidance for Industry
					
		
		September 2017


	Download the  Final Guidance Document
	    
      	      		Read the Federal Register Notice 

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    PrintDocket Number:
		    FDA-2015-D-4644
	    	    		    Issued by:
		    Guidance Issuing Office
          Center for Drug Evaluation and Research


This guidance provides recommendations to pharmaceutical companies interested in participating in a program involving the submission of chemistry, manufacturing, and controls (CMC) information containing emerging technology to FDA. The program is open to companies that intend to include the technology as part of a regulatory submission including investigational new drug applications (IND), original or supplemental new drug applications (NDA), abbreviated new drug applications (ANDA) or biologic license applications (BLA), or application-associated Drug Master Files (DMF) reviewed by the Center for Drug Evaluation and Research (CDER), and where that technology meets other criteria described in this guidance. This program does not cover products reviewed by the Center for Biologics Evaluation and Research.


 
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						All written comments should be identified with this document's docket number: FDA-2015-D-4644.

                                                                                  Content current as of:
      08/24/2018
         
                  
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