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ArticlePubMed 6
In spite of their limitations, these studies are the first to demonstrate a capacity of exogenously administered NAC to reach the CNS
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Instead, when FDA asked why Purolea had not validated its manufacturing process prior to commercial distribution (a bedrock requirement under 211.100), the staff responded: we were not aware of the validation requirement, because the AI agent we used never told us it was required. ( [2] )
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