In Brief: FDA's Immunology Devices Panel
This article was originally published in The Gray Sheet
Executive Summary
FDA's Immunology Devices Panel: Convenes Nov. 30 and Dec. 1 at the Holiday Inn in Gaithersburg, Maryland. On Nov. 30, the panel will review two premarket approval applications for "an in situ hybridization assay to measure a prognostic market in breast tumor tissues" and "an assay to measure a urinary marker to aid in the detection of recurrence in bladder cancer patients." On Dec. 1, the panel will discuss a citizen's petition, submitted by Centocor in June 1995 ("The Gray Sheet" June 5, p. 5), to reclassify from Class III to Class II all serum tumor markers intended to monitor recurrence in previously treated cancer patients. For further information, contact Peter Maxim at 301/594-1293...