Another Reorganization for CDER: Its Office of Management

Regulatory News

The US Food and Drug Administration's Center for Drug Evaluation and Research (CDER) is already off to a busy start this year, having released new long-sought functions on its website, launched its new Office of Pharmaceutical Quality (OPQ) and hired a permanent director for its Office of Generic Drugs.

The changes, it seems, aren't stopping there. Last week, CDER also announced a reorganization of its Office of Management in the hopes of streamlining its approach to managing the nation's drug regulators.

In an email to FDA staff on 8 January 2015, CDER Director Janet Woodcock said the new management staff will include two additions: a strategic programs and initiatives staff, and an ethics liaison staff.

The overall will also see the creation of two new divisions:

• The Division of User Fee Management and Budget Formulation (DUFMBF), which will oversee the generics branch, legal and operations branch, and the brands branch.
• The Division of Budget Execution and Resource Management (DBERM), which will replace the Division of Management and Budget and oversee three branches: budget execution, acquisitions support and financial accountability.

A third division, the Division of Management Services (DMS), which oversees most of CDER's HR functions, will continue to exist with some minor changes. CDER also said it plans to eliminate a total of six branches:

• Program and Resource Management Branch
• Management Analysis Branch
• Program and Resource Management Branch
• Management Analysis Branch
• Program Management Services Branch
• Interface Management Branch

Woodcock said the reorganization will help CDER to "better meet the management services needs of a growing Center with expanding authorities" under the Food and Drug Administration Safety and Innovation Act (FDASIA) of 2012.