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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. This effort will allow 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 working to build on our past successes and strengths by implementing problem-focused, interdisciplinary, team-based approaches so we can meet the challenges of evolving science, new drug platforms, and new drug targets, while incorporating the patient voice in development.

The modernization of the New Drugs Regulatory Program will be a long-term process of continuous improvement involving multiple initiatives. We have begun implementation of some initiatives and will continue over the course of 2020. Additional information will be added as programs and projects progress.

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, 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.

  2. 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 and focus on the important application-specific issues, uses a team-based interdisciplinary model, and increasingly incorporates the patient perspective, providing an integrated assessment.   

  3. 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 lifecycles, both before and after approval. 

  4. Managing Talent
    Attract, develop, and retain outstanding people.

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

  5. 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 proposed organizational structure changes within the Office of New Drugs (OND), we plan to standardize various regulatory and business processes. Our proposed organizational structure creates 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.

  6. 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

These programs and projects are currently underway.

Integrated Review for Drug Marketing Applications
Directly supports the following strategic objectives: Scientific Leadership, Integrated Assessment, Operational Excellence, and Benefit-Risk Monitoring.

We are implementing a new integrated review process and documentation template to support reviewers in conducting a scientifically-rigorous review that efficiently documents regulatory decisions.

The guiding principles of this initiative are issue-focused assessments, enhanced communication both within the review team and with the applicant, and stronger interdisciplinary collaboration.  FDA believes that the format and content of the new integrated review will provide a clearer description of FDA’s analysis of the scientific issues raised by the application and will thereby more effectively communicate the basis for the regulatory decision.

The integrated review process includes the following enhancements:

  • A review issue tracking tool to be utilized from investigational new drug (IND) development to approval and post-approval.
  • New roles to support the review team and allow reviewers to focus on the science and regulatory aspects of the application.  Clinical data scientists will support clinical safety data verification and analyses, and medical editors will provide editing and formatting services.
  • Purposeful interdisciplinary working meetings with early leadership involvement to focus on an integrated assessment of specific review issues.

To illustrate the new integrated review template, which has three main components – an executive summary, an interdisciplinary assessment, and appendices – we rewrote the original review for Pifeltro (doravirine) and Delstrigo (doravirine, lamivudine, and tenofovir disoproxil fumarate) to provide an example. The drug approval package, including the original review, is available on Drugs@FDA. On June 26, we published a federal register notice seeking feedback on this new approach. The review for Dovato (dolutegravir, lamivudine), the first prospective review to use the new process and template, is also available for illustration.

IND Review Management
Directly supports the following strategic objectives: Integrated Assessment and Operational Excellence.

INDs are applications to the FDA to permit testing of investigational new drugs in humans.  Initiatives to streamline the scientific review and management processes during IND development (the development of the drug from the time an IND is approved) are being implemented.  The first initiatives focus on the 30-day review of the initial IND application and on review of key clinical protocols, with new processes and issue-based templates. The new processes and templates include enhancements to:

  • Promote consistency across divisions and reduce redundant documentation practices
  • Foster collaboration and enable better knowledge management
  • Establish procedures that standardize the review process, clearly define roles and responsibilities, and improve our ability to provide high-quality feedback to drug companies in a timely manner
  • Develop a risk-based approach to categorize incoming information from drug companies, and identify protocols that should follow a more expeditious review process

Post-market Safety Management
Directly supports the following strategic objectives: Scientific Leadership, Integrated Assessment, and Benefit-Risk Monitoring.

New post-market safety management processes are being designed to create a standardized and consistent approach to managing drug safety after drugs are approved.  The new standardized post-market drug safety framework will enhance:

  • Cross-disciplinary, collaborative, science-focused assessments
  • Clear roles, responsibilities, and governance
  • Information Technology (IT)-enabled processes to enhance knowledge management, and fit-for-purpose analytic tools to promote optimal evaluations

Assessing Talent
Directly supports the following strategic objective: Managing Talent.

FDA plans to enhance its efforts to assess talent for the New Drugs Regulatory Program by developing an effective and consistent process for hiring, onboarding, training and evaluating new staff. FDA also intends to more fully implement 21st Century Cures Act pay authorities to hire exceptional talent.

Administrative Operations
Directly supports the following strategic objective: Operational Excellence.

Efforts are underway to optimize administrative and clerical staff roles, structure, and functions to enhance customer focus and employee engagement.

Transition Management & Reorganization of the New Drugs Regulatory Program
Directly supports the following strategic objectives: Scientific Leadership and Operational Excellence.

The New Drugs Regulatory Program will not only include modernized processes and documentation, but a proposed restructuring of the clinical offices and divisions within the Office of New Drugs (and changes in the Office of Translational Sciences).  The proposed changes will create offices that align interrelated disease areas, and divisions with clearer and more focused areas of expertise. The proposed changes increase the number of offices that oversee our review divisions from six to eight - and increases the number of clinical review divisions from our current 18 divisions to 26 plus seven divisions of pharmacology/toxicology. In addition to enabling greater efficiency, these envisioned changes will help us to better understand the diseases intended to be treated by the drugs we evaluate for approval – another way we aim to enhance our knowledge management.

Additional information on the goals of Modernization: