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          Advanced Manufacturing Technologies Designation ProgramSearch for FDA Guidance Documents GUIDANCE DOCUMENT
	Advanced Manufacturing Technologies Designation Program
					
		
		December 2023


	Download the  Draft  Guidance Document
	    
      	      		Read the Federal Register Notice 

    Draft

	  	    Not for implementation. Contains non-binding recommendations.
	  
	  	    This guidance is being distributed for comment purposes only.
	  
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    Print**Submit Comments by** 02/12/2024
	  	Submit Comments Online
			Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the FDA considers your comment on a draft guidance before it begins work on the final version of the guidance, submit either online or written comments on the draft guidance before the close date. 
				If unable to submit comments online, please mail written comments to:
				Dockets Management
				 Food and Drug Administration 
				 5630 Fishers Lane, Rm 1061 
				 Rockville, MD 20852
				 All written comments should be identified with this document's docket number: FDA-2023-D-4974
	Docket Number:
		    FDA-2023-D-4974
	    	    		    Issued by:
		    Guidance Issuing Office
          Center for Biologics Evaluation and Research
          Center for Drug Evaluation and Research


FDA encourages the early adoption of advanced manufacturing technologies (AMTs) that have the potential to benefit patients by improving manufacturing and supply dependability and optimizing development time of drug and biological products. These technologies can be integral to ensuring quality and supporting a robust supply of drugs that are life-supporting, life-sustaining, of critical importance to providing healthcare, or in shortage. AMTs can directly improve product quality through higher capability manufacturing designs and enhanced controls (e.g., leading to fewer human errors). This draft guidance provides recommendations to persons and organizations interested in participating in FDA’s Advanced Manufacturing Technologies Designation Program, which is intended to facilitate the development of drugs, including biological products, manufactured using an AMT that has been designated as such under the program.

                                                                                  Content current as of:
      12/12/2023
         
                  
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