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Regulatory Review of Novel Therapeutics — Comparison of Three Regulatory Agencies

BACKGROUND: The upcoming reauthorization of the Prescription Drug User Fee Act focuses on improving the review process for new drug applications at the Food and Drug Administration (FDA). METHODS: Using publicly available information from the FDA, the European Medicines Agency (EMA), and Health Cana...

Disgrifiad llawn

Wedi'i Gadw mewn:
Manylion Llyfryddiaeth
Prif Awduron: Downing, Nicholas S., Aminawung, Jenerius A., Shah, Nilay D., Braunstein, Joel B., Krumholz, Harlan M., Ross, Joseph S.
Fformat: Artigo
Iaith:Inglês
Cyhoeddwyd: 2012
Pynciau:
Mynediad Ar-lein:https://ncbi.nlm.nih.gov/pmc/articles/PMC3504361/
https://ncbi.nlm.nih.gov/pubmed/22591257
https://ncbi.nlm.nih.govhttp://dx.doi.org/10.1056/NEJMsa1200223
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