New Visualization Models of Designation Pathway and Group Categorization of Device–Drug and Device–Biologic Combination Products Classification in the United States: Analysis of FDA Capsular Decisions

OBJECTIVE: The developer and sponsor of new combination products in US needs to forecast which classification and designation to the regulatory scheme of drug, biological product, or device would be required for the new products by the Food and Drug Administration (FDA). To improve the predictabilit...

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Detalles Bibliográficos
Autores principales: Uemura, Nobuo, Kasanuki, Hiroshi, Umezu, Mitsuo
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Springer International Publishing 2021
Materias:
Original Research
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8238755/
https://www.ncbi.nlm.nih.gov/pubmed/33844189
http://dx.doi.org/10.1007/s43441-021-00276-x

Internet

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8238755/
https://www.ncbi.nlm.nih.gov/pubmed/33844189
http://dx.doi.org/10.1007/s43441-021-00276-x

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