BioCentury
ARTICLE | Regulation

Debating device vs. drug approvals

November 2, 1998 8:00 AM UTC

WASHINGTON - The differing requirements for approval of devices and drugs was one of the undercurrents at last week's meeting of the FDA's Gastroenterology and Urology Devices Advisory Panel review of Cypress Bioscience Inc.'s Prosorba column for treatment of rheumatoid arthritis.

The panel voted 10-1 to recommend approval of Prosorba, a cylinder through which a patient's blood plasma is passed through highly purified protein A immobilized on a silica matrix, then recombined with blood cells and returned to the patient's body. (see BioCentury Extra, Oct. 30). ...