FDA clears SNM IND application

Nuclear medicine organization SNM said that the U.S. Food and Drug Administration (FDA) has approved an SNM-sponsored, multicenter investigational new drug (IND) application for F-18-labeled 3'-deoxy-3'-fluorothymidine (FLT).

The FDA has agreed to allow multiple sources of FLT to be evaluated, reviewed, and accepted for use under a single IND, according to the Reston, VA-based society. In addition, the FDA has also agreed to base the IND review process for acceptance of the various investigational FLT products on the end-product specifications, SNM said.

SNM's centralized, multicenter IND application was made possible, in part, through a letter of cross-reference to a master FLT IND held by the Cancer Imaging Program at the National Cancer Institute, according to the organization. Active clinical trials utilizing FLT are expected to begin in 2009, SNM said.

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