Impact of non‐binding FDA guidances on primary endpoint selection in Alzheimer's disease trials

INTRODUCTION: The U.S. Food and Drug Administration (FDA)'s guidances help describe the agency's current thinking on regulatory issues and serve as a means of informal policymaking that is non‐binding. This study examines the impact of two guidance documents for Alzheimer's disease (A...

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Detalles Bibliográficos
Autores principales: Yu, Jeffrey C., Hlávka, Jakub P., Joe, Elizabeth, Richmond, Frances J., Lakdawalla, Darius N.
Formato: Online Artículo Texto
Lenguaje:English
Publicado: John Wiley and Sons Inc. 2022
Materias:
Research Articles
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8943597/
https://www.ncbi.nlm.nih.gov/pubmed/35356740
http://dx.doi.org/10.1002/trc2.12280

Internet

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8943597/
https://www.ncbi.nlm.nih.gov/pubmed/35356740
http://dx.doi.org/10.1002/trc2.12280

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