Carregant...

Continued Regulatory Actions Affecting the Use of Erythropoiesis-Stimulating Agents

The FDA sent a “Complete Response and Safety Labeling Change Order” to the sponsors of ESAs on July 30, ordering changes to ESA labels in three important ways. For the first time, the FDA used its statutory authority to order a sponsor to make revisions to a product label.

Guardat en:
Dades bibliogràfiques
Autor principal: Hagerty, Karen
Format: Artigo
Idioma:Inglês
Publicat: American Society of Clinical Oncology 2008
Matèries:
Accés en línia:https://ncbi.nlm.nih.gov/pmc/articles/PMC2793911/
https://ncbi.nlm.nih.gov/pubmed/20856755
https://ncbi.nlm.nih.govhttp://dx.doi.org/10.1200/JOP.0863501
Etiquetes: Afegir etiqueta
Sense etiquetes, Sigues el primer a etiquetar aquest registre!