FDA Releases Two Draft Oncology Trial Guidances

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FDA Issues Two Draft Oncology Trial Guidances Focusing on Survival Assessments and Radiopharmaceutical Dosage

J.W. Schomisch

August 21, 2025 at 09:42 AM EST

The FDA released two draft guidances related to oncology clinical trials, which discuss ways to assess overall survival and dosage optimization of therapeutic radiopharmaceuticals. The assessment guidance provides recommendations to sponsors on the assessment of overall survival in randomized oncology clinical trials conducted to support marketing approval of drugs and biolog... Read More

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FDA Issues Two Draft Oncology Trial Guidances Focusing on Survival Assessments and Radiopharmaceutical Dosage

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