LEADER 01363nam 2200361Ia 450 001 9910699111803321 005 20230902162255.0 035 $a(CKB)5470000002400782 035 $a(OCoLC)466868919 035 $a(EXLCZ)995470000002400782 100 $a20091118d2009 ua 0 101 0 $aeng 135 $auran||||||||| 181 $ctxt$2rdacontent 182 $cc$2rdamedia 183 $acr$2rdacarrier 200 00$aGuidance for industry$b[electronic resource] $epostmarketing studies and clinical trials, implementation of section 505(o) of the Federal Food, Drug, and Cosmetic Act 210 1$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and Research :$cCenter for Biologics Evaluation and Research,$d[2009] 215 $a1 online resource (13 pages) 300 $a"Draft guidance." 300 $a"Drug safety." 300 $a"July 2009." 517 $aGuidance for industry 606 $aClinical trials$xGovernment policy$zUnited States 615 0$aClinical trials$xGovernment policy 712 02$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 $a9910699111803321 996 $aGuidance for industry$93434577 997 $aUNINA