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Molecular Imaging Homepage

SHINE secures rights to new method for Lutetium-177 production Generate Lu-177 at greater speed and scale

FDA gives green light to new United Imaging PET/MR scanner The uPMR 790 HD TOF performs total-body scans within 20 minutes

FDA reminder for properly eluting rubidium 82 generators prompted by 'recent incidents' Using incorrect solutions puts patients at risk

Generating higher quality PET images 100x faster at MSK 'No one has done PET imaging in this way before'

Louisiana getting $14 million Center for Molecular Imaging and Therapy Increasing research opportunities, collaboration and radiopharmaceuticals

PET uncovers abnormal tau deposits associated with CTE in live subjects May enable diagnosis of CTE in living people one day

DOE transfers land to Coquí Pharma for isotope production facility Will be used primarily to produce Mo-99

Amyloid PET scans help with Alzheimer's clinical management New insights from the 11,000 patient IDEAS study

United Imaging's total-body PET scanner shows promise in four new studies Faster scans, lower dose and 'a level of detail never seen in PET'

NorthStar buys IBA electron accelerators for Mo-99 production Will increase production capacity and efficiencies

Cardinal Health to distribute IRE ELiT's 68-Ga generators

by John R. Fischer , Staff Reporter

It also proposed placing a temporary exemption to the 400-elution limit of generators almost immediately, and for the use of cyclotron-generated gallium with an acqueous target to increase production at mostly academic sites for the next three to six months to relieve the need for a GMP-grade generator in particular locations.

Another aspect is raising awareness and educating radiopharmacies about these generators and how they can apply for the appropriate licensure status with the Nuclear Regulatory Commission and applicable state regulatory bodies to obtain and use them.
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“The market is demanding quick access, but the licensing process, focused primarily on public safety, can take time to address with new technology, and timing may vary between different jurisdictions,” he said. “When regulators seek feedback from their licensed stakeholders, Cardinal Health offers its experience and expertise to encourage discussions on comprehensive and efficient regulatory procedures, with standardization and consistency across the different regulatory bodies, when possible.”

The NETSPOT scan is required for the administration of Lutathera, the only therapeutic for treating neuroendocrine tumors. The U.S. Advanced Accelerator Applications (AAA) has rapidly adopted NETSPOT, expanding the network of pharmacies distributing it and raising demand for it among imaging providers to 500 as of June 2018.

Distribution of the generators is expected to begin prior to the end of 2018.

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