01550nam 2200421Ia 450 991069897530332120090619150030.0(CKB)5470000002398120(OCoLC)404070022(EXLCZ)99547000000239812020090619d2004 ua 0enguran|||||||||txtrdacontentcrdamediacrrdacarrierGuidance for industry[electronic resource] addendum to E2C clinical safety data management : periodic safety update reports for marketed drugsRockville, 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,[2004]9 pages digital, PDF fileTitle from PDF title page (viewed on June 19, 2009)."ICH"."February 2004".Guidance for industry Clinical pharmacologyDrugsSide effectsReportingDrugsTestingClinical pharmacology.DrugsSide effectsReporting.DrugsTesting.Center for Drug Evaluation and Research (U.S.)Center for Biologics Evaluation and Research (U.S.)International Conference on Harmonisation.GPOGPOBOOK9910698975303321Guidance for industry3434577UNINA