Postmarketing commitments for novel drugs and biologics approved by the US Food and Drug Administration: a cross-sectional analysis

BACKGROUND: Postmarketing commitments are clinical studies that pharmaceutical companies agree to conduct at the time of FDA approval, but which are not required by statute or regulation. As FDA increasingly adopts a lifecycle evaluation process, greater emphasis will be placed on postmarket evidenc...

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Detalles Bibliográficos
Autores principales: Wallach, Joshua D., Luxkaranayagam, Anita T., Dhruva, Sanket S., Miller, Jennifer E., Ross, Joseph S.
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BioMed Central 2019
Materias:
Research Article
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6572730/
https://www.ncbi.nlm.nih.gov/pubmed/31203816
http://dx.doi.org/10.1186/s12916-019-1344-3

Internet

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6572730/
https://www.ncbi.nlm.nih.gov/pubmed/31203816
http://dx.doi.org/10.1186/s12916-019-1344-3

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