Postmarketing safety of orphan drugs: a longitudinal analysis of the US Food and Drug Administration database between 1999 and 2018

BACKGROUND: Information about the specific regulatory environment of orphan drugs is scarce and inconsistent. Uncertainties surrounding the postmarketing long-term safety of orphan drugs remain. This study aimed to evaluate the labelling changes of orphan drugs and to identify postmarketing safety-a...

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Detalles Bibliográficos
Autores principales: Fan, Min, Chan, Adrienne Y. L., Yan, Vincent K. C., Tong, Xinning, Lau, Lauren K. W., Wan, Eric Y. F., Tam, Eliza Y. T., Ip, Patrick, Lum, Terry Y., Wong, Ian C. K., Li, X.
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BioMed Central 2022
Materias:
Research
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8728968/
https://www.ncbi.nlm.nih.gov/pubmed/34983612
http://dx.doi.org/10.1186/s13023-021-02166-9

Internet

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8728968/
https://www.ncbi.nlm.nih.gov/pubmed/34983612
http://dx.doi.org/10.1186/s13023-021-02166-9

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