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          PET Drug Products - Current Good Manufacturing Practice (CGMP)Search for FDA Guidance Documents GUIDANCE DOCUMENT
	PET Drug Products - Current Good Manufacturing Practice (CGMP)
					
		
		December 2009


	Download the  Final Guidance Document
	    
      	      		Read the Federal Register Notice 

    Final

	  
	  
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    PrintDocket Number:
		    FDA-1998-D-0025
	    	    		    Issued by:
		    Guidance Issuing Office
          Center for Drug Evaluation and Research


This guidance is intended to help positron emission tomography (PET) drug producers better understand FDA’s thinking concerning compliance with the current good manufacturing practice (CGMP) regulations. The guidance addresses resources, procedures, and documentation for all PET drug production facilities, academic and commercial. In some cases, the guidance provides practical examples of methods or procedures that PET drug production facilities can use to comply with the CGMP requirements.


 
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						All written comments should be identified with this document's docket number: FDA-1998-D-0025.

                                                                                  Content current as of:
      08/24/2018
         
                  
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