Table Of Content

Center for Biologies Evaluation Research St ANMJAL REPORT FY 95 C39r CENTER FOR BIOLOGICS EVALUATIONAND RESEARCH FY 95ANNUAL REPORT . (CoveringthePeriodOctober1,1994throughSeptember30, 1995) SectionI ExecutiveSummary Section11 MissionStatement SectionIII StrategicPlan- CBER2004Vision; Goals SectionIV SignificantAccomplishmentsForFY95 - TotalBiologicalActions-BiologicalLicensingActivities;Biological InvestigationalNewDrugApplications 4 - SignificantApprovals 5 - ScientificAccomplishments-includingFacilityForBiotechnology Resources; SpecialInterest 10 -OtherRegulatoryAccompUshments 14 - PrescriptionDrugUserFeeActHighlights 15 - ReinventingGovernment 16 - PolicyDevelopments 17 -InternationalHarmonization 18 - InformationManagementHighlights-including SMART 19 -ManagementAccomplishments 23 -OrganizationalChanges NATIONALINSTITUTESOFHEALTH 26 NiH LIBRARY JUL-M996 BLDG 10, 10CENTER DR. BETHESDA, MD 20892-1150 SectionV ProgramDescriptions 32 - Pre-Market 32 - PostMarket 32 - Science 33 - InternationalHarmonization 35 - InformationManagement Systems 36 - OrganizationandManagement 36 - People, FacilitiesandEquipment 37 SectionVI Resources 39 Appendix 41 Meetings, Workshops&. Seminars AdverseEvents CBERFirstActionPerformanceforApplications ApplicationDataSummary TotalCBERSubmissionsReceived EXECUTIVE SUMMARY TheCenterforBiologiesEvaluationandResearch(CBER)is responsibleforensuringthesafety, efficacy, potencyandpurityof biologicalandrelatedproductsintendedforuseinthetreatment, preventionorcureofdiseasesinhumansaswellasthesafetyofthe nation'ssupplyofbloodandbloodproducts. Theprimary responsibilityofCBERistoreviewthesafetyand efficacyof vaccines, bloodproducts, certaindiagnosticproductsand other biologicalandbiotechnology-derivedhumanproducts. CBER's activitiesinclude: • evaluatingthesafetyandeffectivenessofbiological productsbeforemarketing, andmonitoringthepreclinical andclinicaltestingofnewbiologicalproducts; • licensingbiologicalproductsandmanufacturing establishments, includingplasmapheresiscenters, blood banks, vaccineandbiotechnologymanufacturers; • ADDS programandpolicyactivities, includingresearchon AIDStherapeuticproducts, diagnostictestsandvaccines; • researchtoestablishproduct standardsanddevelop improvedtestingmethods; • compliance, lotreleaseprogramandpostmarket surveillance; • PDUFAgoalsmet, newresearchprograms, newregulatory initiatives(managedreviewprocessforallproducts). MISSION STATEMENT ThemissionofCBERistoprotectandenhancethepubUchealth throughregulationofbiologicalandrelatedproductsincluding bloodanddiagnostics, vaccines, andbiologicaltherapeutics accordingto statutoryauthorities. Theregulationoftheseproducts isfoundedonscienceandlawto ensuretheirpurity, potency, safety, efficacyand availability. InflilfilUngourmissionasaCenteroftheFDA, weapplythe followingprincipleswiththehighestethicalstandardsandintegrity: • Wedevelop, maintain, and supportahighquahtyand diverseworkforce; • Weensurecompliancewithlawsandregulationsthrough review, education, surveillance, andenforcement; • Weconductresearchasanessentialelementofscience- baseddecision-making; • Weareproactiveandencourageinnovation, cooperation and collaboration.