> ## Content Index
> Fetch the complete content index at: https://www.fdaweb.com/llms.txt
> Use this file to discover other available public pages before exploring further.

# Agency Has ‘Evolved’ in the Last 10 Years: Verdun
- URL: https://www.fdaweb.com/agency-has-evolved-in-the-last-10-years-verdun/
- Published: 2025-05-15T12:00:00.000Z
- Updated: 2026-09-14T15:11:54.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5159192

CBER Office of Therapeutic Products super office director **Nicole Verdun** says the agency has evolved considerably in the last 10 years to better serve as a partner in the search for new therapies for rare diseases. Speaking on a panel at the 5/9 Friends of Cancer Research [public meeting](https://friendsofcancerresearch.org/event/unlocking-next-generation-therapies/?ref=fdaweb.com) on “Unlocking Next-Generation Therapies,” Verdun said the agency has grown in its ability to problem-solve to overcome issues, and thus the advice it gives today might be very different from what it would have said a decade ago.

As the panel discussed ways to speed new therapies to patients, noting that science is not the barrier at this point, Verdun urged other stakeholders to take advantage of FDA’s existing programs and said the agency knows it must “right-fit” its advice in terms of a specific patient population and the availability or lack of other therapies.

She stressed the need for those developing new therapies for rare diseases to speak with FDA early about chemistry, manufacturing, and controls (CMC), and noted there have been instances in which FDA gave specific CMC advice but it wasn’t followed.

Greater information sharing was raised as one potential aid to faster development and approvals, and Verdun said it is important to be more intentional in non-competitive information sharing to help move the process forward. “FDA is comfortable allowing leverage across programs,” she said.

Panel members suggested that FDA make more of an effort to communicate the services it has available and consider publishing de-identified case studies of its work with developers so small start-ups know what the agency can and does do and don’t have to reinvent the wheel. Having that information available could also help investors decide if the risk is acceptable, said Stanford University’s **Crystal Mackall**.

While the panel did not venture into political discussions, **Holly Lynch** from the University of Pennsylvania’s Perelman School of Medicine pointed out that if FDA does not have sufficient staff, it won’t matter what services and help it can provide.