Clinical Chemistry and Clinical Toxicology Devices Panel
December 7, 1999
Draft Panel Questions
FDA Regulation of Home-Use In Vitro Diagnostic Devices, Steven Gutman, MD, MBA, and Kimber Richter, MD, CDRH, FDA
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*Hillier, Sharon L., PhD, etc. "Association Between Bacterial Vaginosis and Preterm Delivery of a Low-Birth-Weight Infant," The New England Journal of Medicine, Dec. 28, 1995, Vol. 333, No. 26, pp. 1737-1742
*Sagawa, Tadashi, etc, "Vaginal and Cervical pH in Bacterial Vaginosis and Cervicitis during Pregnancy," Hokkaido J Med. Sc., 70(6), pp. 839-846, 1995.
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