Recent headlines have raised valid concerns about staffing and internal shifts at the FDA. The FDA Law Blog highlighted the strain on reviewers following the dismissal of senior staff, and Reuters reported that the FDA has let go of most of its negotiators for upcoming pharma user fee talks. These developments point to uncertainty, especially in areas like rare disease and advanced therapies, where predictability is paramount.
However, from where we stand — in daily, real-time interaction with FDA teams — the experience has been remarkably steady, even encouraging.
At RareMoon, we’ve recently cleared an IND for a first-in-clinic novel therapeutic product, received timely responses to RMAT submissions, and had record-fast meeting minutes returned. These aren’t isolated events. We’re in contact with CBER’s Office of Therapeutic Products (OTP) multiple times a week and continue to be met with clarity, professionalism, and even gratitude from agency staff.
Are timelines always a concern for our clients? Absolutely. But in reality, given the broader context, the FDA is currently exceeding our expectations. Our Regulatory Project Managers have remained consistent and engaged, and we’ve seen no drop in responsiveness or commitment to public health. In fact, the agency’s support has been instrumental in helping our clients navigate complex and time-sensitive regulatory paths.
We also recognize that part of the reason our experience may differ is due to how we approach agency interactions. We make it a priority to submit clear, aligned meeting minutes that rarely require edits — and we show up prepared, respectful of the agency’s time and process. That level of collaboration makes a difference.
We continue to acknowledge the pressure the agency is under and the very real implications of staffing changes. From our seat at the table, the FDA continues to show up — for sponsors, for patients, and for progress.
And for that, we’re incredibly grateful!
