Monthly Archives: October 2016

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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