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035   $a(EXLCZ)995470000002402132
100   $a20100115d2009      ua             0
101 0 $aeng
135   $auran|||||||||
181   $ctxt$2rdacontent
182   $cc$2rdamedia
183   $acr$2rdacarrier
200 00$aGuidance for industry and review staff$b[electronic resource] $elabeling for human prescription drug and biological products : determining established pharmacologic class for use in the highlights of prescribing information
210  1$aSilver Spring, MD :$cU.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research ;$aRockville, MD :$cCenter for Biologics Evaluation and Research,$d[2009]
215   $a1 electronic text (7 pages)
300   $a"Good Review Practice."
300   $a"Labeling."
300   $a"October 2009."
517   $aGuidance for industry and review staff 
606   $aDrugs$xLabeling
606   $aBiologicals$xLabeling
615  0$aDrugs$xLabeling.
615  0$aBiologicals$xLabeling.
712 02$aCenter for Drug Evaluation and Research (U.S.)
712 02$aCenter for Biologics Evaluation and Research (U.S.)
801  0$bGPO
801  1$bGPO
906   $aBOOK
912   $a9910699378103321
996   $aGuidance for industry and review staff$93444689
997   $aUNINA