Table 3.
Minimum and Maximum Number of Post-Approval Activities on Pregnancy (Proposed by Sponsor/MAH and Requested by HAs) and Their Impact Outcomes.
| Types of Post-approval Activities | Pregnancy Registry | Database Study | Enhanced PV | Interventional Study | Drug Utilization Study | |||||
|---|---|---|---|---|---|---|---|---|---|---|
| Range of Post-approval Activitiesa | Min n = 73 | Maxc n > 146 | Min n = 37 | Max n = 98 | Min n = 20 | Max n = 70 | Min n = 8 | Max n = 32 | Min n = 11 | Max n = 34 |
| Impact of post-approval activitiesb | ||||||||||
| Inclusion of data in the PI | 8 | 32 | 4 | 16 | 1 | 4 | 2 | 8 | 1 | 4 |
| Modification of pregnancy recommendation in the PI | 3 | 12 | 1 | 4 | 1 | 4 | 2 | 8 | 0 | 0 |
| Removal of missing information from RMP | 3 | 12 | 5 | 20 | 1 | 4 | 0 | 0 | 2 | 8 |
| Reclassification of safety concern to important risk | 1 | 4 | 0 | 0 | 1 | 4 | 0 | 0 | 0 | 0 |
| Development or modification of risk minimization measures | 2 | 8 | 2 | 8 | 2 | 8 | 0 | 0 | 0 | 0 |
| Initiation of another post-approval activity to generate data | 5 | 20 | 2 | 8 | 2 | 8 | 0 | 0 | 2 | 8 |
| Evaluation of new safety finding | 4 | 16 | 2 | 8 | 0 | 0 | 1 | 4 | 0 | 0 |
| Poster/abstract/publication | 10 | 30 | 3 | 12 | 4 | 16 | 2 | 8 | 1 | 4 |
aNumbers in this table were calculated as follows: Survey participants who either proposed or were requested by HAs to conduct at least 1 post-approval activity on pregnancy were asked to classify the number of their activities into 4 different category ranges (0, 1–4, 5–10, > 10). The count of survey participants reporting at least 1 activity was multiplied by the category range, providing a minimum and a maximum count for each activity by type. Numbers presented in this table combine numbers of Sponsor-proposed activities and HA-requested activities to give total activity counts.
bSurvey participants were asked if any post-approval activity on pregnancy resulted in a specified impact and to classify these activities into 4 different category ranges (0, 1–4, 5–10, > 10). The count of survey participants reporting at least 1 impact was multiplied by the category range, providing a minimum and a maximum count of activities for each impact type.
cThe category range > 10 was reported by 2 survey participants for the pregnancy registry activity; therefore, a precise maximum count cannot be provided for this activity.