Pregnancy and Fetal Outcomes Following Exposure to Modafinil and Armodafinil During Pregnancy.

This cohort study uses data from the US Provigil/Nuvigil Pregnancy Registry to assess prevalence of fetal major congenital malformations after exposure to modafinil and armodafinil during pregnancy.

Challenges of post-authorization safety studies: Lessons learned and results of a French study of fentanyl buccal tablet.

Purpose: Recruiting and retaining participants in real-world studies that collect primary data are challenging. This article illustrates these challenges using a post-authorization safety study (PASS) to assess adverse events (AEs) experienced with fentanyl buccal tablet (FBT) over 3 months of treatment.

Methods: This was an observational, prospective, multicenter study in France conducted over 1 year.