LEADER 01466nam 2200385Ia 450 001 9910698127103321 005 20090324130955.0 035 $a(CKB)5470000002395712 035 $a(OCoLC)316867708 035 $a(EXLCZ)995470000002395712 100 $a20090324d2008 ua 0 101 0 $aeng 135 $auran||||||||| 181 $ctxt$2rdacontent 182 $cc$2rdamedia 183 $acr$2rdacarrier 200 00$aGuidance for industry$b[electronic resource] $econtents of a complete submission for the evaluation of proprietary names 210 1$aSilver Spring, MD :$cU.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research (CDER) ;$aRockville, MD :$cCenter for Biologics Evaluation and Research (CBER),$d[2008] 215 $ai, 17 pages $cdigital, PDF file 300 $aTitle from PDF title page (viewed on Mar. 24, 2009). 300 $a"Draft guidance." 300 $a"November 2008." 517 $aGuidance for industry 606 $aDrugs$xLabeling$xEvaluation 606 $aBrand name products$xEvaluation 615 0$aDrugs$xLabeling$xEvaluation. 615 0$aBrand name products$xEvaluation. 712 02$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 $a9910698127103321 996 $aGuidance for industry$93434577 997 $aUNINA