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A warning letter places a firm on official notice, and inadequate corrections can lead to escalations such as import alerts, civil penalties, product seizures, or even consent decrees with third party oversight

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Ideally, to be predictive of an in vivo effect, in vitro neutralization assays should mimic the in vivo conditions under which nAbs encounter virus as closely as possible

Piazzolla et al

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in some embodiments, the gel formulation also has an immediate or rapid release component for delivery of the active agent to the desired target site