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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Bibliographic Details
Main Authors: Sally W. Schwarz, Clemens Decristoforo
Format: Artigo
Language:Inglês
Published: SpringerOpen 2019-05-01
Series:EJNMMI Radiopharmacy and Chemistry
Subjects:
Radiopharmaceuticals
Regulation
FDA
EMA
Preclinical safety
Toxicity testing
Online Access:http://link.springer.com/article/10.1186/s41181-019-0059-2
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