FDA, SNM, RSNA to meet about trials, regulations for PET drug manufacturing

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The FDA, SNM and the Radiological Society of North America (RSNA) are hosting a joint two–topic workshop, April 13–14, at the National Institutes of Health in 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, said SNM.

The second day of the workshop will consist of an interactive tutorial on ways to address the FDA regulatory expectations for PET drugs, particularly with respect to final regulation on current good manufacturing practice issued on December 2009, added SNM. The new regulations, known as 21 CFR Part 212, will take effect on Dec. 12, 2011 and 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.

The workshop is free and open to the public said the Reston, Va.-based SNM.