原创力文档gao-Regenerative Medicine Therapeutic Applications, Challenges, and Policy Options-此为英文文档.docx
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UnitedStatesGovernmentAccountabilityOffice
ReporttoCongressionalCommittees
July2023TECHNOLOGY
July2023
RegenerativeMedicine
TherapeuticApplications,Challenges,andPolicyOptions
GAO-23-105430
Thecoverimagedisplaysastylizedrepresentationofahumanbody,circledbyiconsrepresentingkeyregenerativemedicinetechnologies.
Coversource:GAO;Anttoniart/derariad/greenvector/mariia/microone/texvector/(images).|GAO-23-105430
TECHNOLOGYASSESSMENTRegenerative
TECHNOLOGYASSESSMENT
RegenerativeMedicine
TherapeuticApplications,Challenges,andPolicyOptions
WhatGAOfound
Regenerativemedicineoffersthehopeofbeingabletorestoreorreplacecell,
tissue,andorganfunctionsaffectedbydisease,injury,oraging.Thismayeventuallyhelpmanageorcuremanyconditionsthatarecurrentlyconsideredchronic,
untreatable,orterminal.
ExamplesofDiseasesandRegenerativeMedicineTherapiesThatMightAddressThem
GAOidentifiedmanychallengesthatmayaffectthedevelopmentanduseofregenerativemedicinetechnologiesandtherapiesincluding:
Challengesrelatedtostandardization.Standardsarerules,conditions,guidelines,oragreed-uponpracticesthatareadoptedwithinanindustrytoprovidedevelopers
withacommonframeworkandpromoteconsistency.Developingregenerativemedicinestandardsischallengingbecausethesetechnologiesandtherapiesarecomplexandrapidlyevolving.Inaddition,standardsrequireconsensusfrom
stakeholders,whichmaybedifficulttoobtain.
Challengesrelatedtoregulation.TheFoodandDrugAdministration(FDA)ensuresthesafety,efficacy,andsecurityofhumanmedicalproductsintheU.S.through
regulation.Regenerativemedicinefaceschallengesrelatedtoregulation,includingdifficultynavigatingacomplexregulatoryframework,uncertaintyoverwhich
regulatorypathwayismostappropriateforcertainemergingtechnologiesandtherapies,andstaffingshortagesatFDAandcollaboratingagen
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