When doing your background work in preparation for a new or updated submission, it can be helpful to understand the structure, personnel and process in the FDA offices with whom you may be working. There are a number of ways you can gather this information, including the organizational structure web pages (see this previous post), the review process desk reference guide, and the relevant sections of the Manual of Policies and Procedures or the Compliance Program Guidance Manual (for example, this section on the Prior Approval Inspection Program). The leaders of the division and each office have their biographies posted on the CDER Leadership Bios page, which was recently updated to include the biography of Elizabeth Jungman, Director of the Office of Regulatory Policy. CDER’s Offices and Divisions page also has references to personnel and procedures that may be useful.

Text Copyright © 2019 Katrina Rogers