Safety under the regulatory spotlight — 129 documents in 90 days

74 documents in the last 30 days alone

This concentration of safety-related regulatory documents may indicate a tightening cycle, particularly if the recent 30-day surge reflects faster issuance of clarifications, expectations, or enforcement-oriented guidance. Sponsors should consider that regulators may be sharpening their focus on signal detection, post-marketing surveillance, and benefit-risk justification, so companies with safety programs should watch for shifts in adverse event reporting expectations, risk management language, and data transparency standards.