Policy· June 8, 2026 · 11 min readBIOSECURE Act and the API supply chain: DMF strategy for launch teamsHow the BIOSECURE Act reshapes API sourcing from China, affects DMF strategy, and creates compliance obligations for pharmaceutical...By Ran Chen#BIOSECURE Act#API Manufacturing#Drug Master File
Global· June 8, 2026 · 11 min readSouth Korea MFDS biosimilar reform 2026: what US launch teams need to knowHow South Korea's 2026 MFDS regulatory reforms — streamlined biosimilar review, CDMO framework, and AI-assisted evaluation — affect...By Ran Chen#Biosimilars#Regulatory#FDA Approval