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METHODS: To investigate the safety of blue dye for lymphatic mapping in pregnant women, the pharmacokinetics of methylene blue dye were examined in 10 nonpregnant women, and the results were extrapolated to estimate maximal fetal exposure to the dye
Guan R, Lv J, Xiao F, Tu Y, Xie Y, Li L
For anyone bringing a device to market, Id recommend that you: Start your regulatory planning early FDA has stated that the average 510(k) submission is now more than 1,000 pages long
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Repeatability is essential for long-term scientific testing
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