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# NDRP Modernization Successes Lead to ‘Permanent Initiative’
- URL: https://www.fdaweb.com/ndrp-modernization-successes-lead-to-permanent-initiative/
- Published: 2024-06-25T12:00:00.000Z
- Updated: 2026-09-14T14:34:10.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5157246

The CDER New Drug Regulatory Program (NDRP) has had some successes since its inception in 2017 and is now a permanent initiative, according to Office of New Drugs Special Program Staff associate director **Yoni Tyberg**. Writing in an online *CDER Conversation*, Tyberg [says](https://www.fda.gov/drugs/cder-conversations/modernizing-new-drugs-regulatory-program?ref=fdaweb.com) the modernization aimed to increase the efficiency and effectiveness of CDER offices in response to a rapid increase in drug development complexity and volume in the past two decades and an anticipation of future growth.

The NDRP opened, Tyberg says, with a diagnosis of areas for improvement and potential paths forward that led to a comprehensive modernization plan with these six core strategic objectives:

- Scientific Leadership — growing agency scientific expertise and clarifying pathways to regulatory approval;
- Integrated Assessment — critically, collaboratively, and consistently assessing whether information in drug approval applications meets legal and regulatory requirements;
- Operational Excellence — standardizing workflow, business processes, roles, and responsibilities to improve operational efficiency and enable agency scientists to focus on science;
- Benefit-Risk Monitoring — systematically monitoring the benefits and risks of approved drugs pre- and post-approval to effectively protect the American public; and
- Knowledge Management — facilitating the identification, capture, distribution, and effective use of information.

Tyberg says CDER also created seven workstreams, or clusters of tasks, to achieve each objective and to measure its progress and impact.

“The NDRP modernization has already reached a number of significant milestones,” he writes. He says there are some short-term goals and next steps they hope to accomplish in the coming year, along with some efforts planned for the future.

NDRP “will continue to foster collaboration, increase efficiency through optimized workload distribution, and build new programs to help address unmet needs,” Tyberg concludes. “As science continues to evolve and change, the NDRP program can adapt to continue its modernization mission.”