US and EU radiopharmaceutical diagnostic and therapeutic nonclinical study requirements for clinical trials authorizations and marketing authorizations

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 a simila...

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Detalles Bibliográficos
Autores principales: Schwarz, Sally W., Decristoforo, Clemens
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Springer International Publishing 2019
Materias:
Debate
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6529498/
https://www.ncbi.nlm.nih.gov/pubmed/31659486
http://dx.doi.org/10.1186/s41181-019-0059-2

Internet

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6529498/
https://www.ncbi.nlm.nih.gov/pubmed/31659486
http://dx.doi.org/10.1186/s41181-019-0059-2

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