A retrospective cohort study analyzed 552 new drugs approved by the FDA between 2011 and 2023, of which 179 (32.4%) had at least one PREA pediatric study requirement, with a final cohort of 166 drugs and 338 studies. About half (51.8%) of the studies evaluated efficacy. Of the 222 studies with a deadline of December 31, 2024, only 24.3% were completed on time, more than half (56.8%) were extended by an average of 2.9 years. Ten years after drug approval, 59.5% of studies were completed, although 92.0% were expected. Of the 117 drugs with planned studies, 54.7% (64 drugs) had an updated pediatric label, with a mean time of 5.6 years for approval and 8.3 years for a lack of safety or benefit label. Only 52.8% of drugs had labeling changes reflecting data from the PREA studies, although 90.4% were expected to discontinue within 10 years. The study highlights delays in completing and updating labeling. A limitation is limited public data on study design and reasons for delays.