title: The 21st Century Cures Act: can the regulatory framework survive the "cures"?
authors.affiliation: Escola Nacional de Saúde Pública Sergio Arouca, Fundação Oswaldo Cruz, Rio de Janeiro, Brasil.
authors.forename: Claudia Garcia Serpa
authors.initials: CG
authors.lastname: Osorio-de-Castro
authors.affiliation: Instituto de Medicina Social, Universidade do Estado do Rio de Janeiro, Rio de Janeiro, Brasil.
authors.forename: Rosângela
authors.initials: R
authors.lastname: Caetano
authors.affiliation: Escola Nacional de Saúde Pública Sergio Arouca, Fundação Oswaldo Cruz, Rio de Janeiro, Brasil.
authors.forename: Vera Lúcia Edais
authors.initials: VL
authors.lastname: Pepe
mesh_terms: D001938:Brazil; D018795:Device Approval / Q000331:legislation & jurisprudence*; D017277:Drug Approval / Q000331:legislation & jurisprudence* / Q000379:methods; D055808:Drug Discovery / Q000379:methods / Q000639:trends*; D033161:Government Regulation; D006801:Humans; D014481:United States; D014486:United States Food and Drug Administration / Q000331:legislation & jurisprudence*