Safety under the regulatory spotlight — 239 documents in 90 days

107 documents in the last 30 days alone

This concentration of activity around safety may indicate a tightening cycle, with regulators placing greater emphasis on risk characterization, post-market surveillance, and the robustness of safety narratives in submissions. Companies with safety programs should consider watching for shifts in adverse event signal expectations, more stringent benefit-risk framing, and any recurring themes in labeling, REMS, or pharmacovigilance guidance, as this could suggest higher scrutiny rather than a broad loosening of standards.