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Modernizing the New Drugs Regulatory Program

In 2017, CDER began the modernization of the New Drugs Regulatory Program (NDRP), a multi-year framework to increase the efficiency and effectiveness of CDER offices. The modernization is in response to a rapid increase in drug development complexity and volume in the past two decades and the anticipation of future growth — fueled in part by the recent breakthroughs in genetic science, personalized medicine advances, and a greater focus on rare diseases and disease subtypes. To keep pace, CDER began this initiative to continuously improve its regulatory science and review process for drug applications.

In this CDER Conversation, Yoni Tyberg, associate director of the Special Program Staff in the Office of New Drugs (OND), discusses the modernization, its accomplishments, and its impact on public health. A comprehensive list of the achievements is available in the NDRP Modernization - Impact Narrative 2023.

Can you describe the NDRP modernization?

Yoni Tyberg photograph
Yoni Tyberg

The NDRP helps CDER achieve its mission by playing a role in the regulatory review and decision-making for new drug products and original therapeutic biologics. To keep pace with the evolving drug development landscape, the NDRP began a modernization initiative in 2017. The first step was a diagnostic phase to assess areas for improvement and potential paths forward. This helped develop a comprehensive modernization plan describing six core strategic objectives, capturing what we hope to accomplish:

  • Scientific Leadership: Grow our scientific expertise and clarify pathways to regulatory approval.
  • Integrated Assessment: Critically, collaboratively, and consistently assess whether information in drug approval applications meets legal and regulatory requirements.
  • Operational Excellence: Standardize workflow, business processes, roles, and responsibilities to improve operational efficiency, and enable our scientists to focus on science.
  • Benefit-Risk Monitoring: Systematically monitor the benefits and risks of approved drugs pre- and post- approval to effectively protect the American public.
  • Managing Talent: Attract, develop, and retain outstanding people.
  • Knowledge Management: Facilitate the identification, capture, distribution and effective use of information.

At the same time, we created seven workstreams — or clusters of tasks — to achieve each objective and to measure its progress and impact. Once the plan was complete, the NDRP modernization moved to the implementation phase.

What are important accomplishments of the NDRP modernization so far?

The NDRP modernization has already reached a number of significant milestones. Through the work of the advisory committee workstream, the NDRP modernization has improved not only advisory committee structure and efficiency, but also achieved several strategic objectives through the use of the improved committee tools and processes. The workstream enhanced areas of the advisory committee planning process such as clarifying when a committee meeting is appropriate, streamlining the process for recruiting and retaining experts for the committees, and developing accessible resources for FDA review teams. These new resources included a tool to help review teams determine whether an advisory committee meeting is appropriate, an educational reference guide, technology/knowledge management platforms for CDER staff, learning modules for advisory committee experts, and a template to help staff efficiently produce a streamlined advisory committee briefing documents. These changes helped promote more efficient advisory committee meetings that were better able to provide well-informed, clear, and consistent expert advice.

Another successful workstream is Investigational New Drug (IND) Review Management, which helps streamline the IND review process. This workstream has several accomplishments, including successfully implementing new review templates for IND 30-day safety and protocol and amendment reviews across all OND prescription drug divisions to improve flexibility and suitability. It also transitioned the IND 30-day safety reviews into an automated workflow system to enhance efficiency, collaboration, knowledge management, and process standardization. This workstream collected multiple rounds of feedback from reviewers and regulatory program managers to ensure the templates and processes were designed for a specific purpose and implemented successfully.

How does the modernization effort impact public health?

One example of a public health impact is through the NDRP modernization’s Benefit-Risk Monitoring objective, which identifies and evaluates risks across the lifecycle of drugs and biologics—that is, both pre- and post-approval. A large part of benefit-risk monitoring is postmarket safety surveillance of drugs once they are approved and reach the market to identify effects (both positive and negative) not uncovered in the premarket clinical trial setting. The NDRP modernization has created nine Drug Safety Teams to foster collaboration among offices and increase the effectiveness of postmarket safety surveillance.

Another area where the initiative has improved the drug development process relates to our efforts surrounding COVID-19 in 2021. Under the NDRP modernization’s Scientific Leadership objective, CDER created additional pathways for offices to work jointly with partners from within and outside FDA to share understanding of the treatment landscape and help develop safe and effective therapies to treat and prevent COVID-19. These collaborations ensured that CDER provided timely advice on COVID-19 to sponsors, standardized regulatory actions across CDER, and modified trial designs to best evaluate potential therapies within the current standard of care treatment paradigm. The OND review teams also worked closely to address drug shortages of COVID-19 treatments, including tocilizumab and baricitinib.

What does NDRP hope to accomplish in the future?

We have several short-term goals and next steps we hope to accomplish in the coming year, along with a number of endeavors planned for the future. We plan to add improvements based on user input for the dashboards we’ve developed, such as integrating them into the review workflows for easier access to important product lifecycle information. Another planned improvement is for the Information Request (IR) focused dashboard, which provides the ability to search and filter information requests. It will receive additional improvements to help its integration with the review workflows and enable better lifecycle tracking and search capabilities.

The Knowledge Management workstream continuously explores and evaluates new and innovative technologies and trends. We hope to use the knowledge we gain from this workstream to improve learning and development opportunities in the field of Postmarket Safety, such as in our “Essentials of Postmarket Drug Safety Curriculum.” We designed this curriculum to help support CDER staff’s capabilities and to improve their understanding of postmarket safety science, foster knowledge sharing among offices, and encourage collaboration for multi-disciplinary teams.

The NDRP modernization has made significant progress since it began and has now become a permanent initiative. It will continue to foster collaboration, increase efficiency through optimized workload distribution, and build new programs to help address unmet needs. As science continues to evolve and change, the NDRP program can adapt to continue its modernization mission. We plan to provide regular updates of our progress to support the agency's transparency efforts and share our successes with industry, other federal agencies and the public.

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