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Lessons Learned From The Investigational Device Exemption (IDE) Review of Children's Oncology Group Trial AAML1031
The FDA is now exerting its regulatory authority over molecular diagnostics and their assays used for medical-decision making in clinical trials by performing pre-Investigational Device Exemption (IDE) reviews in all phases of clinical trials. This review assesses the analytical performance of the a...
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| Main Authors: | , , , , |
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| Formato: | Artigo |
| Idioma: | Inglês |
| Publicado em: |
2012
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| Assuntos: | |
| Acesso em linha: | https://ncbi.nlm.nih.gov/pmc/articles/PMC3310885/ https://ncbi.nlm.nih.gov/pubmed/22422407 https://ncbi.nlm.nih.govhttp://dx.doi.org/10.1158/1078-0432.CCR-11-2205 |
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