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

New ASNC SPECT Imaging Guideline Addresses Advances in Myocardial Perfusion Imaging
News | SPECT Imaging | June 21, 2018
The American Society of Nuclear Cardiology (ASNC) has published an update to its 2010 guidelines for single photon...
FDA Clears New Imaging Functionalities for Biograph mCT PET/CT Systems
Technology | PET-CT | June 21, 2018
Siemens Healthineers will announce U.S. Food and Drug Administration (FDA) clearance of four new system features for...
PET/CT Changes Care for 59 Percent of Suspected Recurrent Prostate Cancer Cases
News | Prostate Cancer | June 13, 2018
A recently presented investigational clinical trial evaluated the impact of 18F fluciclovine positron emission...
Nuclear imaging scan showing very good tissue delineation. Scan performed on a Biograph Vision positron emission tomography/computed tomography (PET-CT) system from Siemens Healthineers.

Nuclear imaging scan showing very good tissue delineation. It offers crisp overall image quality and sharply delineates the muscle and fat planes, vertebral margins and end plates, billiary radicals, renal calyces, aortic wall and papillary muscles of the heart. Scan performed on a Biograph Vision positron emission tomography/computed tomography (PET-CT) system from Siemens Healthineers.

Technology | PET-CT | June 05, 2018
June 5, 2018 — The U.S.
Emerging Trends in Nuclear Medicine
Feature | Nuclear Imaging | June 04, 2018 | By Jeff Zagoudis
Nuclear imaging and its various modalities have long played an important role in the diagnosis and treatment of numer
News | Computed Tomography (CT) | May 21, 2018
The Istituto Oncologico Veneto (IOV) in Padua, Italy, has acquired MILabs’ latest-generation Versatile Emission...
PET Imaging Agent Could Provide Early Diagnosis of Rheumatoid Arthritis

Coronal 18F-FEDAC PET/CT section of a mouse with collagen-induced arthritis. (A) On day 23 and day 37, increased uptake is noted in the front and hind paws of this mouse with collagen-induced arthritis. (B) Predictive performance of day 23 18F-FEDAC uptake for the development of clinical arthritis. ROC = receiver operating characteristic; Sn = sensitivity; Sp = specificity. Credit: Seoul National University and Ewha Womans University, Seoul, South Korea

News | PET Imaging | May 17, 2018
A novel positron emission tomography (PET) tracer developed by Korean researchers can visualize joint inflammation and...
PET Imaging Shows Protein Clumping May Contribute to Heart Failure Development
News | PET Imaging | May 11, 2018
A team led by Johns Hopkins University Researchers has discovered that protein clumps appear to accumulate in the...
News | Radiopharmaceuticals and Tracers | May 09, 2018
Blue Earth Diagnostics signed an exclusive, worldwide agreement with Scintomics GmbH, Germany, a specialist in...
Overlay Init