Regulatory Update
FDA issues final ruling for regulations regarding cGMP practice for PET radiopharmaceuticals
The FDA has issued a final ruling regarding the current good manufacturing practice (cGMP) for PET radiopharmaceuticals. According to the report, the proposed cGMP regulations were designed to be "sufficiently flexible" to accommodate nonprofit, academically-orientated institutions, and commercial producers. These regulations, effective December 12, 2011, are intended to ensure PET drugs meet the requirements of the Federal Food, Drug and Cosmetic Act regarding safety, identity, strength, quality and purity.
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Business News
Doctors seek aid from business schools
Many physicians are deciding to obtain business school training to cope with the ever-changing pace and paperwork of modern day health care. Nurses, private practice managers and hospital administrators are also seeking guidance on how to analyze the slew of data now accessible to them, with the hope of improving the quality of care and lowering costs.
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Customer Spotlight
MIMA: No risk, no glory
The worst recession in decades is not an ideal time to launch a business, and many would say it is a terrible time to build and move into two new facilities. The uncertainty of the healthcare industry compounds the riskiness of these moves, but for MIMA, taking risks is natural.
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Industry News
PETNET Solutions opens in Spain
PETNET Solutions, a subsidiary of Siemens, is about to open its doors in Madrid, Spain.
For molecular diagnostics, radioactive biomarkers are a key prerequisite in supporting the process of identifying diseases and illnesses. As one of the leading companies in providing quality, reliability, and service, PETNET Solutions operates the industry’s largest network of PET biomarker production facilities with 54 PETNET sites worldwide.
A project team with members from PETNET USA, PETNET Europe, and Siemens Spain joined forces to act on the existing demands for PET biomarkers in the first PETNET center in Spain. PETNET is expected to be ready to start with commercial production, once pending licenses are cleared, in January 2010. The center will deliver biomarkers to imaging facilities in Spain as well as Portugal, if needed.
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PETNET Solutions and the University of New Mexico Cancer Center partner to bring cutting-edge cancer tools to New Mexico
The University of New Mexico (UNM) Cancer Center and global technology leader Siemens Medical Solutions USA, Inc. have signed a 15-year agreement that will provide New Mexicans with the most cutting-edge cancer diagnostic tools available.
On September 15, 2009, the UNM Cancer Center hosted an open house to celebrate the new academic-commercial partnership that will help take cancer diagnosis in New Mexico to a whole new level.
The UNM Cancer Center will house two Siemens’ cyclotrons which will provide radioisotopes to the UNM Cancer Center. In addition, this new radiopharmacy will be the newest distribution site for PETNET Solutions, a Siemens Company, and will serve imaging centers in the southwest region.
The radioisotope production and distribution center will be operated by PETNET Solutions and will become part of PETNET’s radiopharmacy network, currently the world's largest. This new facility will provide reliable delivery of radiopharmaceuticals to meet imaging needs throughout the Southwest. In addition, the PETNET Solutions network offers access to a pipeline for biomarker research.
This new agreement will allow Siemens and the UNM Cancer Center to produce medically useful isotopes, which are a critical component of powerful cancer diagnosis and treatment methods. Imaging biomarkers produced by the new cyclotron that will be installed in the Center can also be used to diagnose and monitor cardiac and neurologic diseases and conditions. In the past, physicians and researchers had to import isotopes from outside the state.
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Educational Opportunities
AMI to educate 18F NaF PET imagers due to CMS decision
The Academy of Molecular Imaging (AMI) will broadcast a medical education program entitled “Sodium Fluoride PET bone imaging in cancer patients” on Jan. 19, 2010, to address the needs of nuclear medicine professionals.
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News in Molecular Imaging
Latest news from Molecular Imaging Insight magazine
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