As of September 1996, the US Food and Drug Administration will regulate PET radiotracers as drugs. The PET community argues that such ‘heavy-handed’ regulation will halt PET's progress as a clinically effective diagnostic technique.
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Gershon, D. Is there a future for clinical PET?. Nat Med 1, 494–495 (1995). https://doi.org/10.1038/nm0695-494
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DOI: https://doi.org/10.1038/nm0695-494