共 13 条
[1]
Medical devices, classification/reclassification
[2]
restricted devices
[3]
analyte specific reagents, 61 Fed. Reg. 10, 484 (1996) (21 C.F.R. Parts 809 & 864)
[4]
FDA needs to regulate 'home brews, Nature Biotechnology, 14, (1996)
[5]
Malinowski M.J., Blatt R.J.R., Tulane Law Review, 71, (1997)
[6]
(1992)
[7]
Emerging technologies. Are diagnostics not ready for the genetic revolution?, Genesis Report, 6, 4
[8]
Genetic factors in drug therapy: Clinical and molecular pharmacogenetics, pp. 607-669, (1993)
[9]
Scarlett T., The relationship among adverse reaction reporting, drug labeling, product liability and federal preemption, Food Drug Cosm. L.J, 46, (1991)
[10]
Saltus R., Survey of labs new tests concerns genetics specialists, (1995)