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          PET Drug Applications - Content and Format for NDAs and ANDAs:  Attachment I: Sample formats for chemistry, manufacturing, and controls (CMC) sections_2011Search for FDA Guidance Documents GUIDANCE DOCUMENT
	PET Drug Applications - Content and Format for NDAs and ANDAs:  Attachment I: Sample formats for chemistry, manufacturing, and controls (CMC) sections_2011
					
		
		September 2011


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    PrintDocket Number:
		    FDA-2000-D-1542
	    	    		    Issued by:
		    Guidance Issuing Office
          Center for Drug Evaluation and Research


Date: August 2011

These sample formats for the chemistry, manufacturing, and controls section have been prepared by the PET Steering Committee in the Center for Drug Evaluation and Research at the Food and Drug Administration. This document represents the Agency’s current thinking on the production of these positron emission tomography (PET) drug products. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. An alternative approach may be used if such approach satisfies the requirements of the applicable statues, regulations, or both.


 
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                                                                                  Content current as of:
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