Author Archives: C. Kubler

Coalition for PET Drugs Sponsors Three Sessions at SNMMI Annual Meeting

The Coalition for PET Drugs recently sponsored three sessions at the 2017 annual meeting of the Society of Nuclear Medicine and Molecular Imaging (SNMMI) in Denver. The sessions focused on various topics relevant to PET drug manufacturers. Each session drew … Continue reading

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SNMMI Comments to FDA on Compounding

SNMMI submitted comments to the FDA on draft guidance “Compounding and Repackaging of Radiopharmaceuticals by State-Licensed Nuclear Pharmacies.” The guidance explains that, under current law, radiopharmaceuticals compounded or repackaged by state-licensed nuclear pharmacies and federal facilities are subject to all … Continue reading

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SNMMI Develops USP Recommendations for Compounded Sterile Radiopharmaceuticals

SNMMI has developed USP recommendations for compounded sterile radiopharmaceuticals. The recommendations aim to address certain common practices in the field of nuclear pharmacy that are not adequately defined by generally accepted practice standards. The society believes there is confusion in … Continue reading

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FDA Issues Draft Guidances on Compounding and Repackaging Radiopharmaceuticals

On December 28th, the FDA issued two draft guidances that describe FDA’s proposed policies regarding the compounding and repackaging of radiopharmaceuticals for human use by state-licensed nuclear pharmacies or federal facilities, and outsourcing facilities. According to FDA, “the policies proposed … Continue reading

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FDA Releases SBIA Summary of eCTD Requirements

The U.S. Food and Drug Administration recently released a summary of the movement to require certain regulatory submissions to conform to the electronic Common Technical Document (eCTD) format. The eCTD has been the standard format for submitting applications, amendments, supplements, … Continue reading

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NRC Licensing Guidance for Eckert and Ziegler Ge-68/Ga-68 Generator

On September 28, 2016, the U.S. Nuclear Regulatory Commission published Licensing Guidance for Eckert and Ziegler GalliaPharm Germanium-68/Gallium-68 Pharmacy Grade Generator. All sections of this guidance apply to both medical licensee and commercial nuclear pharmacy licensee use of this generator … Continue reading

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Sponsored Session from SNMMI Annual Meeting:PET Drug Manufacturing: Living in an FDA-Regulated World

The Coalition for PET Drugs recently sponsored a session focused on FDA topics relevant to PET drug manufacturers. The session was held at the 2016 annual meeting of the Society of Nuclear Medicine and Molecular Imaging (SNMMI) in San Diego. … Continue reading

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