FDA raises bar for foreign site inspections as China trials surge

Following fatalities in Chinese gene therapy trials, the FDA is tightening oversight of foreign clinical trial sites by expanding audits and increasing transparency around inspection findings to ensure data integrity and human subject protections. The move accompanies broader efforts to reshore clinical research and address risks of data from certain geopolitical regions.

This Wire brief sits within Fusion42's coverage of Biotech, and 5 sources have reported it between 21 Aug 2026 and 3 Sep 2026.