The FDA holds a hybrid public meeting on 16 September 2026 on reauthorisation of the Prescription Drug User Fee Act, with comments open until 16 October 2026. PDUFA VIII will govern how the agency reviews new drug applications for financial years 2028 to 2032. For European companies with US ambitions, this is the window in which the review performance you will live with is being written down.
Where the process stands
The current legislative authority for PDUFA expires in September 2027. The FDA negotiated with regulated industry following a public meeting in July 2025, held monthly stakeholder consultations from November 2025 through May 2026, and concluded technical discussions at a meeting on 15 May 2026. A proposed commitment letter was released in August 2026.
After the September public meeting and the close of the comment period, the FDA reviews the comments, revises as necessary, and must submit the commitment letter and its recommendations to Congress by 15 January 2027. Congress then has to legislate before the September 2027 expiry.
Why a US fee statute matters in Athens or Amsterdam
The commitment letter is not primarily about money. It is where the FDA sets out the performance goals and procedural commitments it will meet in exchange for the fees — review clock lengths, meeting types and timelines, and the mechanics of how sponsors interact with the agency during development.
For a European company, three consequences follow:
- Development timing. Meeting availability and review goal dates determine how a US programme sequences against an EU one. A company planning parallel EU and US filings is planning against these commitments.
- Budgeting. Fee levels affect the cost of a US strategy, and disproportionately affect smaller companies. Existing small-business exemptions and waivers are worth understanding before assuming a US route is unaffordable.
- Divergence risk. Where FDA procedure moves and EU procedure does not, the gap has to be managed by the sponsor. Anyone building a single global dossier strategy needs to know where the two systems are drifting apart.
The comment period is genuinely open
Comments close on 16 October 2026. The docket is open to any interested party, not only US-domiciled companies, and European sponsors and trade associations have historically used it. If your organisation has a view on meeting management, review predictability or the treatment of smaller sponsors, this is the mechanism for expressing it — and it closes before the recommendations go to Congress in January.
What to do with this
- Read the proposed commitment letter against your own development timelines rather than in the abstract.
- Identify where your US plan depends on a specific meeting type or review pathway, and check whether the proposal changes it.
- If you intend to comment, work back from 16 October 2026.
- Revisit your EU/US regulatory strategy as the final commitment letter emerges, rather than after PDUFA VIII takes effect in FY2028.
How PQRA helps
Our work is grounded in EU and Greek regulation, but development programmes rarely stop at the EU border. We help clients align EU and US regulatory strategy, plan submission sequencing across both systems, and understand where transatlantic requirements converge and where they genuinely differ — so that a decision taken for one market does not quietly damage the other.
If you are planning a US filing alongside an EU application, talk to our regulatory affairs team.
No responses yet