Modernizing FDA's New Drugs Regulatory Program

FDA’s Center for Drug Evaluation and Research (CDER) has 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.

The modernization of the New Drugs Regulatory Program will be a long-term process of continuous improvement involving multiple initiatives. The modernization focuses on six strategic objectives:

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.

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.  

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.

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.

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.

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.

See: https://www.fda.gov/drugs/regulatory-science-research-and-education/modernizing-fdas-new-drugs-regulatory-program

Posted by Dr. Tim Sandle, Pharmaceutical Microbiology