01536nam 2200385Ia 450 991069911220332120230902162116.0(CKB)5470000002400778(OCoLC)466874920(EXLCZ)99547000000240077820091118d2009 ua 0enguran|||||||||txtrdacontentcrdamediacrrdacarrierGuidance for industry[electronic resource] format and content of proposed risk evaluation and mitigation strategies (REMS), REMS assessments, and proposed REMS modificationsRockville, MD :U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research :Center for Biologics Evaluation and Research,[2009]1 online resource (36 pages)"Draft guidance.""Drug safety.""September 2009."Guidance for industry DrugsRisk assessmentGovernment policyUnited StatesBiologicalsRisk assessmentGovernment policyUnited StatesDrugsRisk assessmentGovernment policyBiologicalsRisk assessmentGovernment policyCenter for Drug Evaluation and Research (U.S.)Center for Biologics Evaluation and Research (U.S.)GPOGPOBOOK9910699112203321Guidance for industry3434577UNINA