Category Archives: PET Drugs

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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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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