Recommendations for the development of rare disease drugs using the accelerated approval pathway and for qualifying biomarkers as primary endpoints

For rare serious and life-threatening disorders, there is a tremendous challenge of transforming scientific discoveries into new drug treatments. This challenge has been recognized by all stakeholders who endorse the need for flexibility in the regulatory review process for novel therapeutics to tre...

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Detalles Bibliográficos
Autores principales: Kakkis, Emil D, O’Donovan, Mary, Cox, Gerald, Hayes, Mark, Goodsaid, Federico, Tandon, PK, Furlong, Pat, Boynton, Susan, Bozic, Mladen, Orfali, May, Thornton, Mark
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BioMed Central 2015
Materias:
Review
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4347559/
https://www.ncbi.nlm.nih.gov/pubmed/25757705
http://dx.doi.org/10.1186/s13023-014-0195-4

Internet

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4347559/
https://www.ncbi.nlm.nih.gov/pubmed/25757705
http://dx.doi.org/10.1186/s13023-014-0195-4

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