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# CDER, CBER Working on START Trial Support Program
- URL: https://www.fdaweb.com/cder-cber-working-on-start-trial-support-program/
- Published: 2024-10-15T12:00:00.000Z
- Updated: 2026-09-14T14:44:04.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5157987

Writing in the CDER year-two annual report of its Accelerated Rare disease Cures (ARC) program, Center director **Patrizia Cavazzoni** says CDER partnered with CBER in 2023 to launch the Support for clinical Trials Advance Rare Disease Therapeutics (START) pilot program. The [report](https://www.fda.gov/media/182662/download?ref=fdaweb.com) says START offers selected participants enhanced communication from FDA staff to address program-specific development issues.

In addition to START, Cavazzoni writes, ARC “has sought to address the unique needs of drug sponsors in developing clinical trials for rare disease drugs by launching and expanding the reach of ARC’s translational science team, a unit of subject matter experts and senior leaders focused on supporting new drug application reviews teams across CDER.”

The report lists these 2023 ARC achievements: 29 rare disease NDA approvals, more than 40 public speaking engagements featuring the ARC program, 13 externally-led patient-focused drug developing meetings on rare diseases supported by CDER staff, 15 patient listening sessions on rare diseases, 32,358 rare disease news subscribers, three ARC quarterly newsletters, and over one million views across 103 social media posts.

In the coming year, Cavazzoni writes, FDA will establish a Rare Disease Innovation Hub to leverage the activities across CDER’s and CBER’s rare diseases program, enhancing existing cross-Center collaboration.