CDER publishes updates on its new drug regulatory program

On June 24, 2024, the FDA published on its website an interview with Yoni Tyberg, deputy director of the Special Program Staff in the Office of New Drugs, regarding the progress of the modernization of the New Drug Regulatory Program (NSCLC). The goal of the NSCLC modernization, which began in 2017, is to increase the efficiency and effectiveness of the Center for Drug Evaluation and Research (CDER) processes. This initiative has been spurred by the ever-increasing development of genetic sciences, personalized medicine and treatments for rare diseases.

According to Tyberg, the NDPR began with a diagnostic phase to assess areas for improvement. A plan was then developed with six main goals: science leadership; assessment center; Operational excellence; monitoring benefits and risks; talent management; and knowledge management. To achieve the goals, seven task clusters were also created. Then the plan entered the implementation phase.

NDRP’s achievements to date include refining the advisory committee structure and improving committee tools and processes through the work of the advisory committee team.

“The workflow has improved areas of the advisory committee planning process, such as clarifying when a committee meeting is appropriate, improving the process of recruiting and retaining experts on committees, and developing available resources for FDA review teams,” Tyberg said (1). “These new resources included a tool to help assessment teams determine whether an advisory committee meeting is appropriate, an educational manual, technology/knowledge management platforms for CDER staff, educational modules for advisory committee experts, and a template to help staff effectively create streamlined advisory committee briefing documents. These changes helped promote more effective advisory committee meetings that could better provide informed, clear and consistent expert advice.”

The Investigational New Drug (IND) Review Unit helped streamline the IND review process and implemented new review templates for 30-day IND safety reviews and protocols and amendments.

“He also transformed the 30-day IND safety reviews into an automated workflow system to increase efficiency, collaboration, knowledge management, and process standardization. This process included multiple rounds of feedback from reviewers and regulatory program managers to ensure that the templates and processes were designed with a purpose in mind and successfully implemented,” Tyberg said.

As part of the NSCLC modernization science leadership, additional CDER office collaboration pathways have been created so that partners within and outside the FDA can share information to develop ways to treat and prevent COVID-19. NSCLC has also had an impact on public health by identifying risks throughout the drug lifecycle as part of the goal of monitoring benefits and risks.

“We have several short-term goals and next steps that we hope to achieve in the coming year, as well as a number of projects planned for the future,” Tyberg said. “We plan to add improvements based on user input to the dashboards we have developed, such as integrating them with review workflows for easier access to important product lifecycle information. Another planned improvement is the Information Requests dashboard, which allows you to search and filter information requests. It will receive additional enhancements that will make it easier to integrate into reviewer workflows and enable better lifecycle tracking and search capabilities.”

More information about the program’s achievements can be found in the tab NSCLC Modernization – Impact Narrative 2023 report.

Reference

1. FDA. Modernization of the program for regulating new drugs. FDA.gov. June 24, 2024

Source: FDA