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Investigating the Food and Drug Administration Biotherapeutics Review and Approval Process: Narrative Review

BACKGROUND: The development, review, and approval process of therapeutic biological products in the United States presents two primary challenges: time and cost. Advancing a biotherapeutic from concept to market may take an average of 12 years, with costs exceeding US $1 billion, and the product may...

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Detalles Bibliográficos
Autores principales:	Bonet Olivencia, Samuel, Sasangohar, Farzan
Formato:	Online Artículo Texto
Lenguaje:	English
Publicado:	JMIR Publications 2021
Materias:	Review
Acceso en línea:	https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7974759/ https://www.ncbi.nlm.nih.gov/pubmed/33661119 http://dx.doi.org/10.2196/14563

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