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

EJNMMI Radiopharmacy and Chemistry

Clemens Decristoforo¹  Sally W. Schwarz² 

[1]0000 0000 8853 2677, grid.5361.1, Department of Nuclear Medicine, Medical University Innsbruck, Innsbruck, Austria

[2]0000 0001 2355 7002, grid.4367.6, Washington University School of Medicine, St. Louis, MO, USA

关键词: Radiopharmaceuticals;    Regulation;    FDA;    EMA;    Preclinical safety;    Toxicity testing;   

DOI  :  10.1186/s41181-019-0059-2

来源: publisher

【 摘 要 】

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 similar direction focussing and refining preclinical safety data requirements for both radiodiagnostics and radiotherapeutics. We here summarize these recent documents from both the US and European perspective.

【 授权许可】

CC BY