LEADER 01497nam 2200397 a 450 001 9910698895903321 005 20090504170403.0 035 $a(CKB)5470000002396902 035 $a(OCoLC)320136370 035 $a(EXLCZ)995470000002396902 100 $a20090504d2009 ua 0 101 0 $aeng 135 $auran||||a|||| 181 $ctxt$2rdacontent 182 $cc$2rdamedia 183 $acr$2rdacarrier 200 00$aGuidance for industry$b[electronic resource] $eintegrated summaries of effectiveness and safety : location within the common technical document 210 1$a[Rockville, 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[2009] 215 $a7 pages $cdigital, PDF file 300 $aTitle from title page (viewed on May 4, 2009). 300 $a"Procedural." 300 $a"April 2009." 320 $aIncludes bibliographical references. 517 $aGuidance for industry 606 $aDrugs$xEffectiveness$zUnited States 606 $aBiologicals$xEffectiveness$zUnited States 615 0$aDrugs$xEffectiveness 615 0$aBiologicals$xEffectiveness 712 02$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 $a9910698895903321 996 $aGuidance for industry$93434577 997 $aUNINA