Experts say MDUFA VI draft letter improves program while addressing FDA resource limits

Industry experts note that the draft commitment letter for the upcoming Medical Device User Fee Amendments (MDUFA VI) offers enhancements over the current framework and takes into account the FDA’s limited resources.

A recent study published in Health Affairs compared oncology drug approvals from 2020 to 2025, finding that China’s regulator approved a higher total number of cancer therapies than the U.S. FDA, while the FDA approved more first‑in‑class medicines and tended to do so more quickly.

The findings suggest that while China is expanding the volume of oncology approvals, the United States continues to lead in pioneering treatments, a dynamic that could shape how companies prioritize regulatory pathways and market entry strategies.