Author Archives: C. Kubler

Important Change to NDA 021870

The Coalition would like to make PET drug manufacturers aware of a change to an FDA-approved application for Fludeoxyglucose F 18 Injection (FDG). This modification involves the radioactivity concentration (strength) for FDG described in new drug application (NDA) 021870, which … Continue reading

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Coalition Comments on Generic Drug User Fee Act

The Coalition for PET Drugs submitted comments to the U.S. Food and Drug Administration (FDA) on the reauthorization of Generic Drug User Fee Act (GDUFA).  In general, the Coalition supports GDUFA and believes that user fees have successfully provided the … Continue reading

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Slide Presentations from “FDA: Imaging Drug Development – Regulatory Issues” CE Session

The Coalition is following up on a message that we posted on May 29. In that posting, we highlighted a session at the recent SNMMI annual meeting entitled “FDA: Imaging Drug Development – Regulatory Issues.” The session was sponsored by … Continue reading

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Sponsored Session from SNMMI Annual Meeting: Current Topics in FDA Reviews and Inspections of PET Drug Manufacturers

As we have done in past years, the Coalition for PET Drug Approval recently sponsored a session focused on FDA topics for PET drug manufacturers. The session was held at the 2015 annual meeting of the Society of Nuclear Medicine … Continue reading

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Important Upcoming Events at SNMMI Annual Meeting in Baltimore

The Coalition would like to make you aware of some important events at the upcoming SNMMI annual meeting in Baltimore. We hope you can attend! On Friday, June 5 from 9 to 10 am in the room Ruth in the … Continue reading

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Coalition Sponsors Session on FDA Topics

The Coalition for PET Drug Approval recently sponsored a session focused on FDA topics for PET drug manufacturers. The session was held at the 2014 annual meeting of the Society of Nuclear Medicine and Molecular Imaging (SNMMI) in St. Louis. … Continue reading

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A Passion for Policy

By: Ashley Mishoe, PharmD Brenda Uratani. To those of us in the positron emission tomography (PET) community, this is a name associated with dedication to PET, a spirit of guidance, and a passion for safety. At the recent SNMMI Mid-Winter … Continue reading

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