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14 p, 7.7 MB Regulatory framework for advanced therapy medicinal products in Europe and United States / Iglesias-Lopez, Carolina (Universitat Autònoma de Barcelona. Departament de Farmacologia, de Terapèutica i de Toxicologia) ; Agustí Escasany, Maria Antònia (Hospital Universitari Vall d'Hebron) ; Obach, Mercè ; Vallano, A. (Servei Català de la Salut)
Advanced therapy medicinal products (ATMPs) are a fast-growing field of innovative therapies. The European Union (EU) and the United States (US) are fostering their development. For both regions, ATMPs fall under the regulatory framework of biological products, which determines the legal basis for their development. [...]
2019 - 10.3389/fphar.2019.00921
Frontiers in Pharmacology, Vol. 10 Núm. JULY (2019) , p. 921  
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