Author Archives: C. Kubler

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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Coalition Comments on PET GMP Recordkeeping Burden

On February 29, 2016, the Coalition submitted comments to the FDA on the burdens associated with the PET drug Good Manufacturing Practice (GMP) regulations at 21 CFR part 212. As previously reported, the FDA issued a Federal Notice on December … Continue reading

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Public Comments for PET GMP Recordkeeping Burden

The Coalition would like to make PET drug manufacturers aware of an announcement from the FDA that appeared in the December 29, 2015, issue of the Federal Register. The notice announces the opportunity for public comment on the annual recordkeeping … Continue reading

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USP Seeking Comments on General Chapter Revisions. Deadline approaching!

The US Pharmacopeia (USP) is currently in the process of revising several general chapters that are important to the nuclear medicine community. The USP sets public standards that serve patients, academia, industry, regulators, healthcare professionals, and other stakeholders. As a … Continue reading

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Reminder: Two-year post approval inspections

The Coalition would like to share some important reminders with PET Drug manufacturers that may be coming up on their two-year post approval inspection. Below is a list of items FDA inspectors recently asked for in one of the current … Continue reading

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