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035   $a(CKB)5470000002400778
035   $a(OCoLC)466874920
035   $a(EXLCZ)995470000002400778
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] $eformat and content of proposed risk evaluation and mitigation strategies (REMS), REMS assessments, and proposed REMS modifications
210  1$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 (36 pages)
300   $a"Draft guidance."
300   $a"Drug safety."
300   $a"September 2009."
517   $aGuidance for industry 
606   $aDrugs$xRisk assessment$xGovernment policy$zUnited States
606   $aBiologicals$xRisk assessment$xGovernment policy$zUnited States
615  0$aDrugs$xRisk assessment$xGovernment policy
615  0$aBiologicals$xRisk assessment$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   $a9910699112203321
996   $aGuidance for industry$93434577
997   $aUNINA