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

 
• By Sue Sutter

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.

PET scan machine
Stakeholders suggested easing the requirement for animal dosimetry data for new PET imaging drugs. • Source: Shutterstock

The US Food and Drug Administration is seeking advisory committee input on a proposal to eliminate some required animal testing for new positron emission tomography (PET) drugs and streamline development.

The Medical Imaging Drugs Advisory Committee will meet 1 August to discuss the circumstances under which the FDA may consider human studies sufficient to allow reasonable radiation absorbed dose (AD) calculations for new PET drugs

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