FDA Warning Letters: A Retrospective Analysis of Letters Issued to Pharmaceutical Companies from 2010–2020

PURPOSE: To launch a pharmaceutical product in the US market, approval from the FDA is required. Pharmaceutical companies undergo FDA pre-approval inspection (PAI for small molecule products) or pre-license approval (PLI for biological products) at their manufacturing sites (including contract devel...

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Detalles Bibliográficos
Autores principales: Rathore, Anurag S., Li, Yuexia, Chhabra, Hemlata, Lohiya, Akshat
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Springer US 2022
Materias:
Original Article
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9377664/
https://www.ncbi.nlm.nih.gov/pubmed/35992018
http://dx.doi.org/10.1007/s12247-022-09678-2

Internet

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9377664/
https://www.ncbi.nlm.nih.gov/pubmed/35992018
http://dx.doi.org/10.1007/s12247-022-09678-2

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