CDER Reorganization to Go Live on March 31

March 28, 2019

The FDA has gotten approval for its overhaul of CDER and work will begin by the end of the month, Director Janet Woodcock announced.

The changes, first proposed last July, include the creation of an Office of Therapeutic Biologics and Biosimilars (OTBB) within the Office of New Drugs (OND), to boost the agency’s capacity to review biosimilars and interchangeable products as well as biologics.

“The increasing complexities and visibility of this program require a dedicated office to efficiently and effectively achieve cross-organizational coordination and collaboration — and advance policy development for these products,” Woodcock said.

As part of the reorganization, OND’s Office of Hematology and Oncology Products (OHOP) will create a third oncology division, a second hematology division, a division of regulatory affairs, and centralized safety reporting and labeling teams.

View today's stories