Translation of Regenerative Medicine Products Into the Clinic in the United States: FDA Perspective

Translational Regenerative Medicine

Volumn , Issue , 2014, Pages 49-74

  Lee, Mark H ^a   Au, Patrick ^a   Hyde, John ^a   Gacchina Johnson, Carmen ^a,b   Heidaran, Mohammad ^a   Karandish, Safa ^a   Boxer, Lynne ^a   Mendicino, Michael ^a   Yoon, Diana ^a,b   Tull, Lori ^a   Arcidiacono, Judith ^a   McCright, Brent ^a   Kaplan, David S ^b   Fink, Donald ^a   Durfor, Charles N ^b   McFarland, Richard ^a   Witten, Celia ^a  

^a CENTER FOR DRUG EVALUATION AND RESEARCH   (United States)

^b CENTER FOR DEVICES AND RADIOLOGICAL HEALTH   (United States)

Author keywords

Biologics; Biomaterials; Cell banks; Consensus standards; Cord blood; Current good manufacturing practices; Gene therapy; Product development lifecycle; Regenerative medicine; Regulatory science; Stem cells; Tissues; Xenotransplantation

Indexed keywords

EID: 84942797071     PISSN: None     EISSN: None     Source Type: Book    
DOI: 10.1016/B978-0-12-410396-2.00005-0     Document Type: Chapter

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