The 2014 FDA amendment to regulations governing the content and format of labeling for human prescription drugs and biological products, which became effective on 30 June 2015, required the inclusion of a “Lactation” subsection in the package insert.40 Information about LA-related risks to the breastfeeding child and recommendations about the use of LAs in breastfeeding mothers can be found in the “Lactation” subsection of specific package inserts.6-10
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