LEADER 01652nam 2200385Ia 450 001 9910698868803321 005 20090512090534.0 035 $a(CKB)5470000002397176 035 $a(OCoLC)320813893 035 $a(EXLCZ)995470000002397176 100 $a20090512d2006 ua 0 101 0 $aeng 135 $auran||||||||| 181 $ctxt$2rdacontent 182 $cc$2rdamedia 183 $acr$2rdacarrier 200 00$aGuidance for clinical investigators, institutional review boards, and sponsors$b[electronic resource] $eprocess for handling referrals to FDA under 21 CFR 50.54 : additional safeguards for children in clinical investigations 210 1$aRockville, MD :$cU.S. Dept. of Health and Human Services, Food and Drug Administration,$d[2006] 215 $ai, 9 pages $cdigital, PDF file 300 $aTitle from PDF title page (viewed on May 12, 2009). 300 $a"December 2006". 517 $aGuidance for clinical investigators, institutional review boards, and sponsors 606 $aMedical research personnel$xGovernment policy$zUnited States 606 $aClinical trials$xGovernment policy$zUnited States 606 $aPediatrics$xResearch$xGovernment policy$zUnited States 615 0$aMedical research personnel$xGovernment policy 615 0$aClinical trials$xGovernment policy 615 0$aPediatrics$xResearch$xGovernment policy 712 02$aUnited States.$bFood and Drug Administration. 801 0$bGPO 801 1$bGPO 906 $aBOOK 912 $a9910698868803321 996 $aGuidance for clinical investigators, institutional review boards, and sponsors$93502728 997 $aUNINA