Table 1.

In and out of scope topics for the regulations, guidelines, and guidance landscape assessment

In scope	Out of scope
Maternal, breastfeeding, and paternal exposure Case reports Aggregate reports Enhanced pharmacovigilance Signal detection Risk management Inclusion/exclusion criteria and enrollment in clinical trials Postmarketing surveillance Pregnancy registries Labeling regulations	Preclinical safety regulations Regulations on contraception Medical device regulations Submission requirements for clinical trial case reports