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...

Descripción completa

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

Internet

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7974759/
https://www.ncbi.nlm.nih.gov/pubmed/33661119
http://dx.doi.org/10.2196/14563

Ejemplares similares