LEADER 01522nam 2200409Ia 450 001 9910696912703321 005 20230902161609.0 035 $a(CKB)5470000002383769 035 $a(OCoLC)567444113 035 $a(EXLCZ)995470000002383769 100 $a20100323d2001 ua 0 101 0 $aeng 135 $auran||||||||| 181 $ctxt$2rdacontent 182 $cc$2rdamedia 183 $acr$2rdacarrier 200 00$aGuidance for industry$b[electronic resource] $eIND meetings for human drugs and biologics, chemistry, manufacturing, and controls information 210 1$aRockville, MD :$cU.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research :$cCenter for Biologics Evaluation and Research,$d[2001] 215 $a1 electronic resource (10 pages) 300 $a"CMC." 300 $a"May 2001." 320 $aIncludes bibliographical references (page 10). 517 $aGuidance for industry 606 $aMedicine, Experimental$xGovernment policy$zUnited States 606 $aBiologicals$zUnited States 606 $aDrug approval$zUnited States 615 0$aMedicine, Experimental$xGovernment policy 615 0$aBiologicals 615 0$aDrug approval 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 $a9910696912703321 996 $aGuidance for industry$93434577 997 $aUNINA