We’ve already seen several updates on the FDA’s activities to modernize their operations, including updates to the web site structure and format, the April announcement of the CDRH reorganization (see this post), and a new CDER web page for FDA-Track (see this post). In June CDER also updated the page describing their plans for modernizing the New Drugs Regulatory Program. This change initiative started in 2017 and will continue through 2020 with program updates in six strategic areas:

1. Scientific Leadership – through hiring and collaborations;
2. Integrated Assessment – implementing a new assessment process which is team-based, focused on early identification of application-specific issues, and incorporates the patient perspective;
3. Benefit-Risk Monitoring – continuing this important role through a unified post-market safety surveillance framework;
4. Managing Talent – since a program is only as good as the people on the team; 
5. Operational Excellence – reorganizing the Office of New Drugs to enable the scientific/clinical experts to focus on science and medicine and manage the regulatory process through a central office of regulatory, program, and administrative experts; and
6. Knowledge Management – expand capabilities to better manage existing and new knowledge.

The updated site also describes the projects currently underway and ends with links to leadership statements on the goals of the modernization initiative. I will be interested in seeing the efforts of the teams working on the integrated review and IND review process updates. I expect the FDA-Track page should also be useful in tracking the impact of the initiative.

Text Copyright © 2019 Katrina Rogers