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Under this alternative pathway, a medical device that has received FDA marketing authorization (that is, has been approved or cleared by, or had a De Novo classification request granted by, FDA) as a Breakthrough Device, for the indication covered by the Breakthrough Device designation, will need to meet the requirements of 412.87(c)

Enhancement of tonic and phasic GABAergic currents following nitric oxide synthase inhibition in hippocampal CA1 pyramidal neurons

An RCT of NAC, 600 mg per day, in pregnant women with a history of preterm birth and bacterial vaginosis showed that women receiving NAC had a lower rate of preterm birth and a higher gestational age at delivery, compared with placebo

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