External panel to review Datscan as FDA questions data
스크롤 이동 상태바
External panel to review Datscan as FDA questions data
기자명
메디칼라이터팀
입력 2009.08.11 00:00
수정 2009.08.11 08:16
댓글 0
General Electric seeks FDA approval of Datscan, its drug that assists in the detection of the neuron deterioration in the brain, which is linked to diseases like Parkinson"s, dementia, and related problems but according to the FDA submitted data from studies does not clearly support its use in patients undergoing brain scans to detect these nervous system disorders. The drug binds to brain proteins in order to improve the quality of the image. The FDA has no safety concerns and Datscan will be reviewed by an FDA panel of external medical experts whether it carries a favorable risk-to-benefit profile as a diagnostic tool. The panel will clarify whether Datscan can differentiate between normal and abnormal neuron loss.