Streamlining first-in-human PET radiopharmaceutical development: FDA's evolving stance on preclinical dosimetry.

Abstract

The U.S. Food and Drug Administration (FDA) has proposed a regulatory shift in the early-phase development of positron emission tomography (PET) radiopharmaceuticals, specifically regarding the requirement for animal-based dosimetry in first-in-human (FIH) studies. This editorial discusses the implications of the FDA's recent Advisory Committee briefing, which supports the omission of preclinical dosimetry under defined conditions for radiopharmaceuticals labeled with ¹⁸F, ¹¹C, ⁶⁸Ga, ⁶⁴Cu, ⁸²Rb, and ¹³N. The proposed policy reflects a shift toward a more streamlined, evidence-based approach to FIH studies while maintaining stringent standards for patient safety.