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VIEW ROLESInsight Brief
FDA’s Draft Guidance on Dosage Optimization for Oncology Therapeutic Radiopharmaceuticals
Implications for Clinical Development
Nov 17, 2025
This insight brief distills the key implications of the FDA’s August 2025 draft guidance on dosage optimization for oncology therapeutic radiopharmaceuticals (RPTs), highlighting its impact on clinical development strategies. The guidance introduces nuanced recommendations for RPT dosing, emphasizing the need for robust trial designs, long-term safety monitoring, and precise dosimetry. It encourages sponsors to move beyond traditional external beam radiation therapy (EBRT) dose limits, adopt individualized approaches, and proactively engage with regulatory authorities. The brief offers actionable strategies for sponsors, including integrating dosimetry early, tailoring eligibility criteria, and leveraging parallel development programs, all aimed at accelerating innovation and ensuring regulatory alignment in the evolving landscape of cancer treatment.
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Oncology Insights
Oncology Expertise that Fuels Your Development Success
Hematology
From first-in-human to global registration, IQVIA delivers end-to-end hematology expertise to accelerate innovation and improve patient outcomes worldwide.