01917oam 2200433Ia 450 991069877200332120090507161916.0(CKB)5470000002396135(OCoLC)317882445(EXLCZ)99547000000239613520090406d2008 ua 0enguran|||||||||txtrdacontentcrdamediacrrdacarrierGuidance for industry[electronic resource] new contrast imaging indication considerations for devices and approved drug and biological productsRockville, MD :U.S. Dept. of Health and Human Services, Food and Drug Administration, Office of Combination Products (OCP) in Office of Commissioner :Center for Devices and Radiological Health (CDRH) :Center for Drug Evaluation and Research (CDER),[2008]18 pages digital, PDF fileTitle from PDF title page (viewed on Apr. 6, 2009)."Draft guidance.""September 2008."Guidance for industry Contrast-enhanced magnetic resonance imagingEquipment and suppliesEvaluationContrast-enhanced ultrasoundEquipment and suppliesEvaluationBiomedical materialsEvaluationContrast-enhanced magnetic resonance imagingEquipment and suppliesEvaluation.Contrast-enhanced ultrasoundEquipment and suppliesEvaluation.Biomedical materialsEvaluation.United States.Food and Drug Administration.Office of Combination Products.Center for Devices and Radiological Health (U.S.)Center for Drug Evaluation and Research (U.S.)GPOGPOGPOBOOK9910698772003321Guidance for industry3434577UNINA