U.S. Food and Drug Administration’s Patient-Focused Drug Development Initiative: Experience with Integration of Patient-Experience Data in a New Drug Application for Esketamine Nasal Spray Plus a Newly Initiated Oral Antidepressant for Treatment-Resistant Depression

The Patient-Focused Drug Development initiative of the U.S. Food and Drug Administration (FDA) aims to ensure that the patient experience of disease and treatment is an integral component of the drug development process. The 21st Century Cures Act and Prescription Drug User Fee Act (PDUFA) VI requir...

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Detalles Bibliográficos
Autores principales: Katz, Eva G., McNulty, Pauline, Levitan, Bennett, Treichler, Patricia, Martynowicz, Jadwiga, Jamieson, Carol
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Springer International Publishing 2021
Materias:
Analytical Report
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8688385/
https://www.ncbi.nlm.nih.gov/pubmed/34623613
http://dx.doi.org/10.1007/s43441-021-00340-6

Internet

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8688385/
https://www.ncbi.nlm.nih.gov/pubmed/34623613
http://dx.doi.org/10.1007/s43441-021-00340-6

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