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Use of Expedited Regulatory Programs and Clinical Development Times for FDA-Approved Novel Therapeutics

This cross-sectional study evaluates the duration between application to US Food and Drug Administration (FDA) and approval for new drugs and biologics in the US from 2015 to 2022.

Detalles Bibliográficos
Autores principales: Wong, Alissa K., Mooghali, Maryam, Ramachandran, Reshma, Ross, Joseph S., Wallach, Joshua D.
Formato: Online Artículo Texto
Lenguaje:English
Publicado: American Medical Association 2023
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10472182/
https://www.ncbi.nlm.nih.gov/pubmed/37651145
http://dx.doi.org/10.1001/jamanetworkopen.2023.31753