01468oam 2200397Ia 450 991069872440332120090423145856.0(CKB)5470000002396614(OCoLC)319065082(EXLCZ)99547000000239661420090423d2008 ua 0enguran|||||||||txtrdacontentcrdamediacrrdacarrierGuidance for industry[electronic resource] providing regulatory submissions in electronic format, postmarketing indivudal case safety reportsRockville, 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,[2008]8 pages digital, PDF fileTitle from PDF title page (viewed on Apr. 23, 2009)."Draft guidance"."June 2008."Guidance for industry Drug testingUnited StatesCase studiesElectronic filing systemsUnited StatesDrug testingElectronic filing systemsCenter for Drug Evaluation and Research (U.S.)Center for Biologics Evaluation and Research (U.S.)GPOGPOGPOBOOK9910698724403321Guidance for industry3434577UNINA