414 records matched your query
01543aam a2200337Ia 4500 001 98AA9DBEFE5F11E2B6A414D3DAD10320 003 SILO 005 20130806010419 006 m d f 007 cr an||||||||| 008 091118s2009 mdu s f000 0 eng d 035 $a (OCoLC)466874920 040 $a GPO $c GPO $d MvI $d SILO 043 $a n-us--- 074 $a 0499-T (online) 086 0 $a HE 20.4702:R 49/3/DRAFT 245 00 $a Guidance for industry $h [electronic resource] : $b format and content of proposed risk evaluation and mitigation strategies (REMS), REMS assessments, and proposed REMS modifications. 246 30 $a Format and content of proposed risk evaluation and mitigation strategies (REMS), REMS assessments, and proposed REMS modifications 260 $a Rockville, MD : $b U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research : $c [2009] 300 $a 1 online resource (36 p.) 500 $a "Draft guidance." 500 $a "Drug safety." 500 $a "September 2009." 650 0 $a Drugs $x Government policy $x Government policy $z United States. 650 0 $a Biologicals $x Government policy $x Government policy $z United States. 710 2 $a Center for Drug Evaluation and Research (U.S.) 710 2 $a Center for Biologics Evaluation and Research (U.S.) 856 40 $u http://purl.access.gpo.gov/GPO/LPS116717 941 $a 1 952 $l USUX851 $d 20160825043706.0 956 $a http://locator.silo.lib.ia.us/search.cgi?index_0=id&term_0=98AA9DBEFE5F11E2B6A414D3DAD10320Initiate Another SILO Locator Search