Table 1.

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

Pregnancy registry	Observational/non-interventional cohort study with or without a comparison group including pregnancy sub-studies in product or disease registries
Database study	Non-interventional study with or without a comparison group that utilizes electronic administrative claims databases and/or EHR or other data to assess pregnancy outcomes Note: For purposes of the survey, responding companies were asked to consider a study that uses a registry as data source under the first category: pregnancy registry
Enhanced pharmacovigilance (PV)	Enhanced follow-up activities or data collection for specific product(s) in addition to what is routinely performed for any spontaneous reports related to pregnancy received by a company. For example, there may be additional time points of follow-up (i.e., subset of products for which follow-up is performed at 6 months after birth and 1 year after birth) or specific data collection form used for specific product(s)
Interventional study	Clinical trial or pharmacokinetic (PK) study with or without comparison groups in pregnant women
Drug utilization study	Study to determine product use in pregnancy to inform on further work (e.g. pregnancy registry, database study, interventional study)