Seminars in Oncology
Volume 29, Issue 3 , Pages 294-300, June 2002

Regulatory issues in tumor marker development☆☆

Division of Clinical Laboratory Devices, Office of Device Evaluation, Center for Devices and Radiological Health, Food and Drug Administration, Rockville, MD.

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 Address reprint requests to Steven Gutman, MD, MBA, Division of Clinical Laboratory Devices, Food and Drug Administration, HFZ-440, 2098 Gaither Rd, Rockville, MD 20850.

☆☆ This is a US government work. There are no restrictions on its use.

PII: S0093-7754(02)50186-X

doi:10.1053/sonc.2002.33140

Seminars in Oncology
Volume 29, Issue 3 , Pages 294-300, June 2002