FDA and industry negotiated the next Prescription Drug User Fee Act (PDUFA) VIII commitment letter, setting review goals for 2028–2032 with themes of stability, transparency and “maturity,” according to BIO VP for Science and Regulatory Affairs Strategy Steve Berman. The letter emphasizes maintaining on-time meetings and predictable review timelines while steering fee growth toward staffing needs without requiring higher industry contributions. It also calls for refinements to written response only (WRO) communications to speed responses to applicant questions. For biotech companies planning filings in the late decade, the commitment letter is a signal of how FDA intends to manage throughput and applicant communication as staffing rebuild efforts continue.