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FDA Experience with Medical Countermeasures under the Animal Rule
The Food and Drug Administration issued a final rule in May 2002 to permit the Agency to approve drugs or license biological products on the basis of animal efficacy studies for use in ameliorating or preventing serious or life-threatening conditions caused by exposure to lethal or permanently disab...
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| Formato: | Artigo |
| Idioma: | Inglês |
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Hindawi Publishing Corporation
2012
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| Acceso en liña: | https://ncbi.nlm.nih.gov/pmc/articles/PMC3177089/ https://ncbi.nlm.nih.gov/pubmed/21991452 https://ncbi.nlm.nih.govhttp://dx.doi.org/10.1155/2012/507571 |
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