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PMID: 456839

Official labeling also states that the solution should be clear and the seal intact

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That is exactly the sort of limitation FDA staff tend to emphasize, and Reuters reported that staff reviewers had already highlighted limited human evidence and safety concerns ahead of the meeting

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In certain embodiments, the pharmacokinetics of the otic formulations or compositions described herein are determined by injecting the formulation on or near the round window membrane of a test animal (including by way of example, a guinea pig, a chinchilla, or a rat)