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Characterizing expanded access and compassionate use programs for experimental drugs

OBJECTIVE: We sought to determine the characteristics of “expanded access” and “compassionate use” programs registered in ClinicalTrials.gov and to determine the percentage of drugs provided through these programs that ultimately received FDA marketing approval. RESULTS: We identified 398 expanded a...

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Detalles Bibliográficos
Autores principales: Miller, Jennifer E., Ross, Joseph S., Moch, Kenneth I., Caplan, Arthur L.
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BioMed Central 2017
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5534121/
https://www.ncbi.nlm.nih.gov/pubmed/28754150
http://dx.doi.org/10.1186/s13104-017-2687-5