News | April 01, 2010

FDA, RSNA, SNM Discuss Clinical Trial Regulations

April 2, 2010 – The FDA, Society of Nuclear Medicine (SNM) and the Radiological Society of North America (RSNA) are hosting a joint two–topic workshop, April 13–14, at the Natcher Conference Center of the National Institutes of Health, Bethesda, Md.

The first day of the workshop will focus on general issues of standardization to control variability and inconsistency in methods of acquisition, interpretation and analysis of images in clinical trials. The second day of the workshop consists of an interactive tutorial on ways to address the FDA regulatory expectations for positron emission tomography (PET) drugs, particularly with respect to the recently issued regulations establishing the current good manufacturing practice (cGMP).

"This workshop offers a unique opportunity to work with the imaging community to help optimize the role of imaging in public health," said Dwaine Rieves, M.D., director of the division of medical imaging products in the FDA’s Center for Drug Evaluation and Research. "This is an example of the FDA’s focus on transparency and its collaboration with stakeholders to ensure that regulated products are both safe and effective."

"We are delighted to be partnering with the FDA and RSNA to bring the molecular imaging community together on the important transition to the new regulations," said Michael M. Graham, Ph.D., M.D., president of SNM. "The PET community remains very focused on preparing to comply with these regulations and is committed to working together to ensure a smooth transition."

"We are very pleased to be working with the FDA and SNM – and the wider community – to discuss critical issues central to the use of imaging as an endpoint in clinical trials," said Daniel Sullivan, M.D., RSNA science advisor. "Standardization is essential to improving the value and practicality of imaging biomarkers."

The FDA published a final regulation on cGMP for the production of PET drugs in December 2009. The new regulations, known as 21 CFR Part 212, take effect on Dec. 12, 2011. All PET drug manufacturers will be required to submit a new or abbreviated drug application for PET drugs in commercial/clinical use by that date. In the interim, U.S. facilities must continue to comply with USP General Chapter 823, which sets standards for the production of PET drugs.

The workshop is free and open to the public. However, early registration is encouraged, as space is limited.

For more information: www.rsna.org/snm/index.html

Related Content

PET Tracer Gauges Effectiveness of Promising Alzheimer's Treatment

Longitudinal PET imaging with 18F-AV45. PET imaging shows the average 18F-AV45 uptake per animal group at 8 and 13 months of age. A significant interaction of genotype treatment was observed in the cortex (p = 0.0248), hippocampus (p = 0.0071) and thalamus (p = 0.0084), indicating reduced [18F]-AV45 uptake in BACE1 inhibited transgenic mice. Credit: MICA, University of Antwerp, Belgium.

News | Radiopharmaceuticals and Tracers | December 28, 2017
In the December featured basic science article in The Journal of Nuclear Medicine, Belgian researchers report on the...
Vital Unveils Newest Vitrea Advanced Visualization Release at RSNA 2017
Technology | Advanced Visualization | December 04, 2017
Vital Images unveiled the newest version of Vitrea Advanced Visualization software, the cornerstone of its imaging...
Michael J. Fox Foundation and Tau Consortium Developing PET Tracers for Neurodegenerative Disease
News | Radiopharmaceuticals and Tracers | October 27, 2017
The Michael J. Fox Foundation for Parkinson's Research (MJFF) and the Tau Consortium announced a funding partnership to...
Netherlands Cancer Institute Exploring Molecular Imaging Technology for Prostate Cancer Surgery
News | Molecular Imaging | October 26, 2017
The Netherlands Cancer Institute (NKI) announced it has received funding from the Dutch Cancer Society (KWF...
SNMMI Publishes New FDG PET/CT Appropriate Use Criteria
News | PET-CT | October 25, 2017
The Society of Nuclear Medicine and Molecular Imaging (SNMMI) has published appropriate use criteria (AUC) for FDG PET/...
Biodex Unveils Atomlab 500 Dose Calibrator and Wipe Test Counter
Technology | Nuclear Imaging | October 19, 2017
Biodex Medical Systems announced the full release of the Atomlab Dose Calibrator and Wipe Test Counter to the market...
ASNC and ASE Team Up to Expand ImageGuide Registry
News | Cardiovascular Ultrasound | October 12, 2017
The American Society of Nuclear Cardiology (ASNC) and the American Society of Echocardiography (ASE) jointly announced...
MR Solutions Showcases Multimodality MRI Solutions on Two Continents
News | Magnetic Resonance Imaging (MRI) | October 11, 2017
October 11, 2017 — MR Solutions took their cryogen-free preclinical multimodality...
Majority of Recurrent Prostate Cancer Patients' Treatment Plan Changed Following Fluciclovine 18F PET/CT
News | Prostate Cancer | October 04, 2017
Blue Earth Diagnostics recently announced the results of a pre-planned interim analysis from an investigational...
News | Business | September 19, 2017
September 19, 2017 — Invicro LLC, a provider of imaging services and software for research and drug development, anno
Overlay Init