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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...
Wedi'i Gadw mewn:
| Prif Awduron: | , , , , , |
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| Fformat: | Artigo |
| Iaith: | Inglês |
| Cyhoeddwyd: |
2012
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| 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 |
| Tagiau: |
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