A pragmatic regulatory approach for complex generics through the U.S. FDA 505(j) or 505(b)(2) approval pathways

The diverse nature of complex drug products poses challenges for the development of regulatory guidelines for generic versions. While complexity is not new in medicines, the technical capacity to measure and analyze data has increased. This requires a determination of which measurements and studies...

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Detalles Bibliográficos
Autores principales: Klein, Kevin, Borchard, Gerrit, Shah, Vinod P., Flühmann, Beat, McNeil, Scott E., de Vlieger, Jon S. B.
Formato: Online Artículo Texto
Lenguaje:English
Publicado: John Wiley and Sons Inc. 2021
Materias:
Commentary
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8597169/
https://www.ncbi.nlm.nih.gov/pubmed/34296458
http://dx.doi.org/10.1111/nyas.14662

Internet

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8597169/
https://www.ncbi.nlm.nih.gov/pubmed/34296458
http://dx.doi.org/10.1111/nyas.14662

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