The role of globalization in drug development and access to orphan drugs: orphan drug legislation in the US/EU and in Latin America [v1; ref status: indexed, http://f1000r.es/3ix]

Autor: Renée J.G. Arnold, Lida Bighash, Alejandro Bryón Nieto, Gabriela Tannus Branco de Araújo, Juan Gabriel Gay-Molina, Federico Augustovski

Publikováno v: F1000Research, Vol 4 (2015)

Compared to a decade ago, nearly three times as many drugs for rare diseases are slated for development. This article addresses the market access issues associated with orphan drug status in Europe and the United States in contrast to the legislation

Externí odkaz: https://doaj.org/article/17a30706e1d8424e89a9ad9dda2b2ec8

The role of globalization in drug development and access to orphan drugs: orphan drug legislation in the US/EU and in Latin America.

Autor: Arnold RJ; Department of Preventive Medicine, Mount Sinai School of Medicine, New York, NY, 10029-6574, USA ; Arnold Consultancy & Technology, New York, NY, 10023-3458, USA ; Quorum Consulting, Inc., San Francisco, CA, 94104, USA., Bighash L; Skaggs School of Pharmacy and Pharmaceutical Sciences, University of Colorado Anschutz Medical Campus, Aurora, CO, 80045, USA., Bryón Nieto A; HEORT, Bogotá, Colombia., Tannus Branco de Araújo G; AxiaBio Life Sciences, São Paulo City, Brazil., Gay-Molina JG; T.I. Salud, Col. Juárez, 06600, Mexico., Augustovski F; Institute for Clinical Effectiveness and Health Policy & Professor of Public Health, Universidad de Buenos Aires, Ciudad de Buenos Aires, C1414CPT, Argentina.

Publikováno v: F1000Research [F1000Res] 2015 Feb 27; Vol. 4, pp. 57. Date of Electronic Publication: 2015 Feb 27 (Print Publication: 2015).