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

Sally W. Schwarz, Clemens Decristoforo

Research output: Contribution to journalArticlepeer-review

5 Scopus citations

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 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.

Original languageEnglish
Article number10
JournalEJNMMI Radiopharmacy and Chemistry
Volume4
Issue number1
DOIs
StatePublished - Dec 1 2019

Keywords

  • EMA
  • FDA
  • Preclinical safety
  • Radiopharmaceuticals
  • Regulation
  • Toxicity testing

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