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  1. Regulatory Science Research and Education

Modernizing FDA's New Drugs Regulatory Program

Reorganization of the Office of New Drugs

In 2017, FDA’s Center for Drug Evaluation and Research (CDER) embarked on an initiative to modernize the New Drugs Regulatory Program. Over the last several years, this effort has allowed CDER to better serve patients and better support staff in their work to carry out the Center’s mission – to protect and promote health by making sure that human drugs are safe and effective for their intended use, that they meet established quality standards, and that they are available to patients. We are continuing to build on our past successes and strengths by implementing problem-focused, interdisciplinary, team-based approaches so we can meet the continuing challenges of evolving science, new drug platforms, and new drug targets, while incorporating the patient voice in development.

The modernization focuses on six strategic objectives:

  1. Scientific Leadership

Grow our scientific expertise and clarify pathways to regulatory approval.

Scientific leadership is vital for our ongoing success. Addressing unmet medical needs is an important part of our public health mission. As such, we aspire to expand our scientific expertise to enable better regulatory decisions. We will continue to hire talented scientists and work to develop long-term career paths for them, so they can become our next generation of seasoned leaders. We will proactively collaborate with academic medical scientists and patient/disease advocates, provide scientific vision and direction, and strategically foster drug development.

  1. Integrated Assessment

Critically, collaboratively, and consistently assess whether information in drug approval applications meets legal and regulatory requirements.

We are implementing a new process with early identification which focuses on important application-specific issues, uses a team-based interdisciplinary model, and increasingly incorporates the patient perspective to provide an integrated assessment.  

  1. Benefit-Risk Monitoring

Systematically monitor the benefits and risks of approved drugs pre- and post- approval to effectively protect the American public.

Ensuring safety of all drugs remains a key component of our mission and our new plans.  We will work to establish a unified post-market safety surveillance framework to monitor the benefits and risks of drugs across their life-cycles, both before and after approval.

  1. Managing Talent

Attract, develop, and retain outstanding people.

We will use various hiring mechanisms such as the 21st Century Cures Act pay authority to enhance efforts to retain our current staff and attract and recruit future staff for the New Drugs Regulatory Program, assuring the next generation of leaders.

  1. Operational Excellence

Standardize workflow, business processes, roles, and responsibilities to improve operational efficiency, and enable our scientists to focus on science.

As part of the organizational structure changes within the Office of New Drugs (OND), we plan to standardize various regulatory and business processes. Our organizational structure will create a central office of regulatory, program and administrative operations servicing all of OND. Our aim is to enable our scientific and clinical experts to focus on what they know best – science and medicine – and allow our regulatory and administrative experts to manage the many processes we conduct.

  1. Knowledge Management

Facilitate the identification, capture, distribution and effective use of information.

Knowledge management is essential to leverage the data we receive from outside sources as well as what we generate from within the FDA. Vast and diverse information is submitted to and generated by the New Drugs Regulatory Program. We plan to markedly expand knowledge management capabilities, which will allow us to better retrieve and utilize information that will improve decision-making and accountability.

Modernization of Programs and Projects

Guided by these strategic objectives, the program formed interdisciplinary workstreams to identify areas for improvement, develop recommendations, design detailed changes, and drive implementation. The workstreams have focused on the following:

  • OND Reorganization
  • Integrated Assessment of Marketing Applications
  • Postmarket Safety
  • Investigational New Drug (IND) Review Management
  • Advisory Committees
  • Assessing Talent and Talent Development & Management
  • Knowledge Management

To ensure the impact and success of these workstreams, implementation follows a set of guiding principles for mobilizing stakeholders and creating shared expectations of progress. The collaborative approach is supported by a central organizing body with subject matter experts to drive implementation, a governance body with frequent check points to create accountability, a network of senior leaders to champion implementation, and ambassadors to expand the impact and embed change in the organization. Implementation is phase-based to enable an iterative test-and-learn approach, allow for ambitious timelines with built in flexibility to revise as conditions change, support coordination with interdependent efforts and organizations, and regularly track progress.

During 2019-2020, the NDRP reorganized the primary super-offices within CDER charged with its daily work. The restructuring resulted in the establishment of offices that better coordinate interconnected disease areas and divisions, each with a more defined and concentrated expertise. The aim was to increase leadership in proportion to the workload by expanding the number of divisions and offices, thereby mitigating bottlenecks. The focus on well-aligned offices and disease-specific divisions was intended to elevate expertise at both the leadership and divisional levels and afford leaders more time to invest in developing colleagues, while reaffirming the commitment to strengthening program operations and the science behind drug evaluation. CDER will continue to evaluate the full impact of the reorganization on an ongoing basis.

Working to complement the reorganization, and in varying stages of implementation, the other workstreams have also demonstrated a positive impact on the NDRP. From 2019 through present, the workstreams have made great strides in modernizing the NDRP program. For example:

  • The Integrated Assessment of Marketing Applications (IAMA) workstream created, refined, and expanded the use of the Integrated Review Template (IRT) and process to include all new molecular entities (NMEs) and original biologics license applications (BLAs). As part of this effort, the workstream developed and implemented the Collaborative Authoring Tool (CAT) to help standardize and streamline the marketing application process. The IAMA workstream has finalized its assessment/review tools. The process and template became mandatory for all NMEs and original BLAs starting in October 2023 (with the exception of the Office of Oncologic Disease (OOD), which has the option to use either IAMA process/template or the Assessment Aide). As a result of these activities, there are now more integrated assessments: articulating the key issues and providing an interdisciplinary perspective on those issues, with reduced redundancy and greater focus. This improves readability of the reviews and ultimately drives increases in understanding and collaboration.
  • The Postmarket Safety workstream developed an Integrated Safety Assessment (ISA) template for use in Newly Identified Safety Signal (NISS) evaluations, created and stood up all 9 planned Drug Safety Teams (DSTs), piloted a new process for pharmacovigilance strategies (PVS) that documents an internal post-approval plan for coordinated monitoring of safety information to enhance postmarketing drug safety surveillance for a drug or drug class, and developed a postmarket safety curriculum for those in the space trying to learn more about key postmarket safety issues. These efforts have focused on improving collaboration on safety-related issues, increasing operational transparency on postmarket safety activities, enhancing approaches to identification and management of potential risks/safety signals, and improving professional development. While the Postmarket Safety workstream has made great strides, it is also currently reimagining its DST strategy to ensure that it provides the most value to all stakeholders in the process and that it standardizes certain applicable processes while also remaining flexible enough to tailor to the needs of certain DST operational requirements.
  • The IND workstream has successfully implemented new templates and processes for reviews across all OND prescription review divisions and aligned divisions in the Office of Translational Sciences, including transitioning 30-Day Safety Assessments into an automated workflow system (Nexus) to enhance efficiency, collaboration, and standardization of processes.
  • The Advisory Committees workstream continues to streamline processes and provide tools and resources to improve AC meetings so that there is consistent, efficient and high-quality AC preparation and consistent high quality AC meetings that provide well-informed and clear expert advice to FDA.
  • To further enhance productivity and value of the regulatory review process, the Talent and Knowledge Management workstreams continue to design and implement a robust applicant screening and talent development process, as well as enhance the overarching approach to managing knowledge through modern technology, analytics, and data governance tools.

These are just a few highlights of the last few years of the NDRP modernization. As progress across the workstreams continues, the iterative and phased approach allows for improvements developed by the workstreams to be applied quickly and visibly.

Collectively, the workstreams are advancing NDRP’s ability to deliver on the six strategic objectives and offer opportunities for those interested to get involved in shaping the future of the program. The New Drugs Regulatory Program Modernization – Impact Narrative Update (2023) (PDF - 11MB) provides a comprehensive look at the continued strategic objectives and achieved impact (including data points, where applicable) of the program modernization’s progress, as well as on continued efforts toward reaching program goals. The report also illustrates how the progress and the contributions to-date further NDRP’s ability to achieve its mission by staying ahead of the rapid growth and evolutions of drug development, review, and surveillance activity, the increasing complexity of innovative therapies under development, and the expanding public engagement in FDA activity.

Additional information on the goals of Modernization:

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