The U.S. FDA announced a less restrictive stance on the use of real‑world evidence (RWE) in device and drug application reviews, saying new guidance will permit submissions that use de‑identified real‑world data sources rather than requiring identifiable patient records. The agency indicated plans to update guidance for drugs and biologics similarly, lowering barriers for RWE‑driven regulatory packages. Concurrently, the Senate passed a version of the National Defense Authorization Act that includes the Biosecure Act provisions restricting federal funding and contracts with certain Chinese biotechnology suppliers (notably firms linked to the 1260H list). The measure forces agencies and grant recipients to phase out risky supplier relationships under varying timelines and tight compliance windows. Taken together, the moves signal a regulatory environment that is both opening to modern evidence streams while tightening on supply‑chain and national‑security risk. Biotech companies will need to adapt regulatory strategies to leverage RWE for approvals while reassessing procurement and manufacturing partnerships tied to covered foreign entities.