The White House is reviewing the next FDA user-fee agreement covering 2028 through 2032, according to sources. The prospective deal would determine how much the biopharma industry pays the agency over a five-year window, shaping FDA resources and, indirectly, review capacity. Separately, industry regulators are also preparing for near-term decision cycles at FDA, with a busy June schedule featuring multiple PDUFA dates and at least eight new products plus three new indications awaiting determinations, including an expected label expansion decision for Ionis Pharmaceuticals’ Tryngolza (olezarsen). Taken together, the developments underscore continued pressure on FDA timelines—while companies plan around both fee-level funding and specific review milestones that influence market entry and label strategy.