Time to inclusion in clinical guidance documents for non-oncological orphan drugs and biologics with expedited FDA designations: a retrospective survival analysis

OBJECTIVES: Drug and biological products that treat rare, serious or life-threatening conditions can receive US Food and Drug Administration (FDA) orphan designation and expedited programme designations (accelerated approval, breakthrough therapy, fast track or priority review) meant to incentivise...

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Detalles Bibliográficos
Autores principales: Rodriguez, Ryan, Brunner, Rachel, Spencer, Samantha, Qato, Dima M
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BMJ Publishing Group 2021
Materias:
Evidence Based Practice
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8719201/
http://dx.doi.org/10.1136/bmjopen-2021-057744

Internet

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8719201/
http://dx.doi.org/10.1136/bmjopen-2021-057744

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