Regulatory enforcement of the marketing of fixed-dose combinations in India: a case study of systemic antibiotics

BACKGROUND: In India, states have licensed the manufacture of large numbers of fixed-dose combination (FDC) drugs without the required prior approval of the central regulator. This paper describes two major regulatory initiatives to address the problem, which began in 2007 and 2013, and examines whe...

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Detalles Bibliográficos
Autores principales: Brhlikova, Petra, Mehta, Aashna, McGettigan, Patricia, Pollock, Allyson M., Roderick, Peter, Farooqui, Habib Hasan
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BioMed Central 2023
Materias:
Research
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10636890/
https://www.ncbi.nlm.nih.gov/pubmed/37950272
http://dx.doi.org/10.1186/s40545-023-00644-y

Internet

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10636890/
https://www.ncbi.nlm.nih.gov/pubmed/37950272
http://dx.doi.org/10.1186/s40545-023-00644-y

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