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US and EU radiopharmaceutical diagnostic and therapeutic nonclinical study requirements for clinical trials authorizations and marketing authorizations
Abstract New regulatory guidance documents from the United States Food and Drug Administration (FDA) and the European Medicines Agency (EMA) have recently been finalized or are in draft format outlining new pathways for preclinical safety testing. The US and the European Union appear to be moving in...
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| Main Authors: | , |
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| Formato: | Artigo |
| Idioma: | Inglês |
| Publicado em: |
SpringerOpen
2019-05-01
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| Colecção: | EJNMMI Radiopharmacy and Chemistry |
| Assuntos: | |
| Acesso em linha: | http://link.springer.com/article/10.1186/s41181-019-0059-2 |
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