Changes in the Review Period of Drug Application and a Drug Lag from the FDA and the EMA: An Industry Survey in South Korea Between 2011 and 2020

BACKGROUND: The Korean regulatory authority has enacted legislation to expedite the new drug approval (NDA) process. However, the effectiveness of such efforts in reducing review time and drug approval delays between Korea and the USA/EU remains to be evaluated. METHODS: We investigated NDA trends i...

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Detalles Bibliográficos
Autores principales: Choi, Hyeyoung, Lee, Hyesung, Park, Bojung, Kim, Chorong, Lee, Jaehyun
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Springer International Publishing 2022
Materias:
Original Research
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10133380/
https://www.ncbi.nlm.nih.gov/pubmed/36539577
http://dx.doi.org/10.1007/s43441-022-00486-x

Internet

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10133380/
https://www.ncbi.nlm.nih.gov/pubmed/36539577
http://dx.doi.org/10.1007/s43441-022-00486-x

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