Category Archives: PET Drugs

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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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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