A method for establishing class III medical device equivalence: sodium hyaluronate (GenVisc 850) for the treatment of knee osteoarthritis

Although the concept of equivalence for drugs (generics) and biologics (biosimilars) has been readily adopted, the concept of equivalence or indistinguishable characteristics for class III medical devices has yet to be specifically addressed regarding a defined regulatory approval process in the US....

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Detalles Bibliográficos
Autores principales: Doros, Gheorghe, Lavin, Philip T, Daley, Michael, Miller, Larry E
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Dove Medical Press 2016
Materias:
Review
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4948701/
https://www.ncbi.nlm.nih.gov/pubmed/27471412
http://dx.doi.org/10.2147/MDER.S104327

Internet

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4948701/
https://www.ncbi.nlm.nih.gov/pubmed/27471412
http://dx.doi.org/10.2147/MDER.S104327

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