The information required by the FDA has 3 subsections: Pregnancy: Information relevant to the use of the drug in pregnant women (eg, dosing, fetal risks) and information about whether there is a registry that collects and maintains data on how pregnant women are affected by the drug Lactation: Information about using the drug while breastfeeding (eg, the amount of drug in breast milk, potential effects on the breastfed child) Females and males of reproductive potential: Information about pregnancy testing, contraception, and infertility as it relates to the drug The pregnancy and lactation subsections each include 3 subheadings (risk summary, clinical considerations, and data) that provide more detail.