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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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| Publicado no: | JMIR Form Res |
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| Main Authors: | , |
| Formato: | Artigo |
| Idioma: | Inglês |
| Publicado em: |
JMIR Publications
2021
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| Assuntos: | |
| Acesso em linha: | https://ncbi.nlm.nih.gov/pmc/articles/PMC7974759/ https://ncbi.nlm.nih.gov/pubmed/33661119 https://ncbi.nlm.nih.govhttp://dx.doi.org/10.2196/14563 |
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