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PET Drug Development Streamlining Proposal Gets Thumbs Up From US FDA Panel

Executive Summary

New approach that would eliminate the need for animal dosimetry data for some positron emission tomography drugs draws advisory committee support, although some panelists raise concerns about limited existing data and longer half-life for copper 64, one of the six radionuclides under consideration.

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PET Imaging Drugs: US FDA Considers Streamlining Pre-IND Dosimetry Data Requirements

An advisory committee will discuss whether the agency may consider human studies sufficient to allow reasonable radiation absorbed dose calculations for new PET drugs containing one of six radionuclides in the absence of drug-specific animal dosimetry data.

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