Table 2.

In-Scope Post-approval Activities (Company-Sponsored) Focused on Data Generation in Lactation.

Lactating women (milk-only) study	Study conducted to detect the presence of a drug in breast milk, quantify or estimate the total amount of a drug transferred into breast milk (when plasma concentrations are known), and evaluate the effects of a drug on milk production (when milk production in lactating women not taking the drug is known)
Lactating women (milk and plasma) study	Milk and plasma collection in lactating women can provide PK data on a drug in a lactating woman, the amount of drug transferred into breast milk, and the effects of a drug on milk production
Mother-infant pair study on lactation	Mother-infant pair study that includes assessment of drug concentrations in infants can provide information on absorption of drugs in infants through breast milk and safety assessments in infants enrolled in these studies
Lactation sub-study in pregnancy registries	Pregnancy registries in which newborns are further observed during exposure via lactation