New Drug and Biologics Approvals in 2019: A Systematic Analysis of Patient Experience Data in FDA Drug Approval Packages and Product Labels

BACKGROUND: The FDA Patient-Focused Drug Development Initiative was launched to ensure the incorporation of the patient voice into drug development and evaluation. Since 2017, the FDA must publish a statement outlining patient experience data (PED) considered in the approval of new drugs. This study...

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Detalles Bibliográficos
Autores principales: Schultz-Knudsen, Katrine, Sabaliauskaite, Ugne, Hellsten, Johan, Lassen, Anders Blaedel, Morant, Anne Vinther
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Springer International Publishing 2020
Materias:
Original Research
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8021513/
https://www.ncbi.nlm.nih.gov/pubmed/33230660
http://dx.doi.org/10.1007/s43441-020-00244-x

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