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391 An Investigation on the Activity of Repurposing Already Marketed Drugs for New Indications from 2015 to 2021.

OBJECTIVES/GOALS: To examine the prevalence of new indications for existing drugs conducted by non-originator companies from 2015 to 2021 and determine how many could qualify for 505(b)(2) under the Food, Drug, and Cosmetics Act. METHODS/STUDY POPULATION: A search within Clinicaltrials.gov was condu...

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Detalles Bibliográficos
Autores principales: Wu, Wenchao, Pacifici, Eunjoo
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Cambridge University Press 2023
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10129525/
http://dx.doi.org/10.1017/cts.2023.426