Temporal Scientific Signals Associated with Regulatory Milestones in Anatomically Targeted Therapeutics: Evidence...

Regulatory approval may occur before or after a research topic becomes prominent in the scientific literature. We examined this temporal relationship using botulinum neurotoxin (BoNT) as a longitudinal case study. We analyzed 2065 anatomy-related BoNT publications indexed in Web of Science and Scopus from 1983 to 2024. The literature was divided into 16 periods based on U.S. FDA approval dates for onabotulinumtoxinA, and indication-related keyword rankings and thematic clusters were compared with the corresponding approval dates. Among the 10 indication groups examined, 7 showed prominent indication-related keywords before FDA approval, 2 showed signals around the time of approval, and 1 showed a post-approval signal. We describe these patterns as "proactive exploration" when scientific attention became prominent before approval and "reactive catalysis" when it became more prominent around or after approval. Differences in the observed lag may be related to target anatomical complexity and market orientation, but this remains conceptual. Overall, the findings show that time-resolved scientometrics can retrospectively identify scientific patterns associated with regulatory milestones. The approach is hypothesis-generating and requires prospective validation before it can be used for regulatory forecasting.