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Four Food and Drug Administration draft guidance documents and the REGROW Act: A litmus test for future changes in human cell‐ and tissue‐based products regulatory policy in the United States?

Modern regenerative medicine research has expanded well past the development of traditional drugs and medical devices with many promising new therapies encompassing an increasingly diverse range of substances, notably cell‐based therapies. These substantial recent developments and the progress in th...

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Detalles Bibliográficos
Autores principales: Yano, Kazuo, Speidel, Alessondra T., Yamato, Masayuki
Formato: Online Artículo Texto
Lenguaje:English
Publicado: John Wiley and Sons Inc. 2018
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6055862/
https://www.ncbi.nlm.nih.gov/pubmed/29702746
http://dx.doi.org/10.1002/term.2683