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          Investigational New Drug Applications for Positron Emission Tomography (PET) DrugsSearch for FDA Guidance Documents GUIDANCE DOCUMENT
	Investigational New Drug Applications for Positron Emission Tomography (PET) Drugs
					
		
		December 2012


	Download the  Final Guidance Document
	    
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    PrintDocket Number:
		    FDA-2012-D-0081
	    	    		    Issued by:
		    Guidance Issuing Office
          Center for Drug Evaluation and Research


This guidance summarizes the investigational new drug application (IND) process for unapproved positron emission tomography (PET) drugs, makes recommendations on how to submit an IND, provides advice on investigational PET drug access options, and describes the process for requesting permission to charge for an investigational PET drug. This guidance does not describe all the considerations relevant to an Expanded Access submission or to an IND Request to Charge submission. For details about these processes, we encourage sponsors to review the applicable regulations and advice available on the FDA Web site, and consult the review division, if necessary.


 
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						All written comments should be identified with this document's docket number: FDA-2012-D-0081.

                                                                                  Content current as of:
      08/24/2018
         
                  
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