CDER Reorganization Enters New Phase, Naming Three New Offices

The FDA has begun the second phase of its CDER reorganization efforts aimed improving drug reviews, including three new offices to handle medicines for cancers, infectious diseases and neurological disorders.

The agency’s CDER modernization initiative was announced last summer and includes multiple phases that make improvements to the center’s administration, structure and regulations.

Phase II establishes an Office of Oncologic Diseases, formerly the Office of Hematology and Oncology Products, led by Rick Pazdur in an acting position. The office will include six divisions — three oncology divisions, two hematology product divisions and the existing division of hematology oncology toxicology.

It will also form the Office of Neuroscience, led temporarily by Billy Dunn. The office will include four divisions — two neurology divisions, a psychiatry division, and a division on anesthesiology, addiction and pain.

Lastly, Phase II will establish the Office of Infectious Diseases, headed in the short-term by John Farley, with divisions on anti-infectives and antivirals.

The agency noted that some INDs, NDAs and BLAs may be affected during the implementation process. Any changes in point of contact for applications currently being reviewed will be explained to sponsors by project management staff, CDER said.