LEADER 01434nam 2200361Ia 450 001 9910698843603321 005 20090519150654.0 035 $a(CKB)5470000002397430 035 $a(OCoLC)326879879 035 $a(EXLCZ)995470000002397430 100 $a20090519d2005 ua 0 101 0 $aeng 135 $auran||||||||| 181 $ctxt$2rdacontent 182 $cc$2rdamedia 183 $acr$2rdacarrier 200 00$aGuidance for industry$b[electronic resource] $eMedWatch form FDA 3550A, mandatory reporting of adverse reactions related to human cells, tissues, and cellular and tissue-based products (HCT/Ps) 210 1$aRockville, MD :$cU.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Biologics Evaluation and Research,$d[2005] 215 $ai, 8 pages $cdigital, PDF file 300 $aTitle from PDF title page (viewed on May 19, 2009). 300 $a"November 2005". 517 $aGuidance for industry 606 $aTissue engineering$xSide effects$xReporting$zUnited States 606 $aHuman cell culture$xGovernment policy$zUnited States 615 0$aTissue engineering$xSide effects$xReporting 615 0$aHuman cell culture$xGovernment policy 712 02$aCenter for Biologics Evaluation and Research (U.S.) 801 0$bGPO 801 1$bGPO 906 $aBOOK 912 $a9910698843603321 996 $aGuidance for industry$93434577 997 $aUNINA