In a blog post last June, CDER director Janet Woodcock announced her proposed changes to the Center’s regulatory and review process for new drugs. These changes include:

• Enhancing recruitment and career development of a diverse group of scientists
• Establishing, integrating, and improving the coordination of multidisciplinary review teams
• Enhancing IT capabilities and information organization to make it easy for staff to find and use scientific and regulatory data, information, and precedent, and help teams better understand the disease to be treated by the proposed drugs
• Emphasizing safety through implementation of a unified post-market surveillance program

The purpose of these improvements is to increase the voice of the patient into the regulatory and review process. No timeline was provided for these improvements other than they will take time to implement. It’s hard to know what this means other than changes are planned and we should stay alert for announcements.

Interestingly, CDER published an update to the Manual of Policies and Procedures on September 5thwhich included updates to the section on the Regulatory Project Management Coordinating Committee (RPMCC) in the CDER (MAPP 7500.1 Rev. 2). This seems like a change that could be related to these improvements.

Text Copyright © 2018 Katrina Rogers