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CENTER FOR DRUG EVALUATION AND
RESEARCH
APPLICATION NUMBER:208081Orig1s000
LABELINGHIGHLIGHTS OF PRESCRIBING INFORMATION
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What is when danger lurks below?
When danger lurks below refers to a situation where the threat or risk is present underneath a certain area or situation.
Who is required to file when danger lurks below?
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When filling out reports related to when danger lurks below, it is important to provide accurate details of the location, nature of the danger, and any measures taken to address the threat.
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The purpose of acknowledging when danger lurks below is to ensure that steps are taken to mitigate the risk and prevent potential harm or accidents.
What information must be reported on when danger lurks below?
Information that must be reported on when danger lurks below includes details of the specific danger, its location, potential impact, and any actions taken to address the risk.
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