Graham: PDUFA VIII Reflects 'America First' Principles
核心洞察
FDA officials outlined the proposed PDUFA VIII (搜索) commitment letter at a public meeting, with Deputy Commissioner Grace Graham calling America First a guiding principle for the recommendations.
The agreement, negotiated by FDA and industry over the past year, would shape drug and biologics review from FY 2028 through FY 2032, after PDUFA VII ends in FY 2027.
Sponsors including US-based Phase 1 trial data would pay half the premarket application fee, and the letter emphasizes manufacturing readiness and CMC review.
FDA officials used a public meeting on Wednesday to reaffirm the administration's priorities in the proposed commitment letter for the Prescription Drug User Fee Act (PDUFA VIII (搜索)). FDA Deputy Commissioner Grace Graham said "America First is a top priority for this administration and a guiding principle," adding that the recommendations presented reflect that stance.
PDUFA VII ends at the end of FY 2027, and the PDUFA VIII (搜索) agreement negotiated by FDA and industry over the past year would shape the agency's drug and biologics review programs from FY 2028 to FY 2032. The proposal includes fee incentives for conducting early-stage trials in the US: sponsors who include clinical trial data from at least one US-based Phase 1 trial would pay only half of the premarket application fee for that submission. Graham also flagged manufacturing readiness as a high priority, saying the CMC portion of an application should not be a lagging indicator and that the agency must be confident an approved product will deliver the results the clinical data promise.
Regulators outlined performance goals and program enhancements spanning premarket drug review, postmarket safety, and chemistry, manufacturing and controls. Industry representatives largely supported the changes, with PhRMA vice president and chief of staff Kristy Lupejkis saying PDUFA VIII (搜索) would help sustain a predictable, efficient, transparent and science-based review process. FDA will review public comments, make revisions, and submit the commitment letter to Congress by the January deadline as part of reauthorization; comments are due to the docket by 16 October 2026.