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FDA Releases Draft Guidance for Nonclinical Radiopharmaceutical Drug Studies

Sept. 15, 2017

The FDA issued new nonclinical study guidance for microdoses of radiopharmaceutical diagnostic drugs.

The guidance is intended to help drug sponsors reduce the time, cost and use of animals for the nonclinical studies.

The guidance notes that because the doses are so small, so is the likelihood for adverse events. It recommends that sponsors tailor the amount of supporting data accordingly.

The guidance lists when specific subjects should be covered in the process or if they may be excluded altogether.

The FDA also recommends that sponsors schedule pre-IND meetings to evaluate drug development recommendations for specific drugs. The draft guidance is open for comment through mid-November.

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