Category Archives: PET Drugs

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 →

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 →

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 →

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 →

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 →

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 →

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 →

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 →

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 →

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 →