title: Global harmonization of regulatory requirements for premarket approval of autologous cell therapies.
authors.affiliation: INTRACEL Corp., Rockville, Maryland, USA.
authors.forename: S M
authors.initials: SM
authors.lastname: Ward
mesh_terms: D017690:Cell Transplantation / Q000331:legislation & jurisprudence* / Q000502:physiology / Q000592:standards; D017277:Drug Approval / Q000331:legislation & jurisprudence*; D005062:European Union; D006801:Humans; D007391:International Cooperation; D007564:Japan; D008962:Models, Theoretical; D014182:Transplantation, Autologous / Q000331:legislation & jurisprudence* / Q000592:standards; D014481:United States; D014486:United States Food and Drug Administration