Congress clears CDER's Office of New Drugs reorg

Sept. 27, 2019

The FDA's CDER announced that the reorganization of certain offices within the New Drugs Regulatory Program (NDRP) has been approved by Congress.

According to the agency, the new structure will allow the FDA to better meet the evolving needs of new drug review by increasing the number of reviewing divisions, allowing each to specialize in certain types of drugs, while also increasing the effectiveness and efficiency of review. This reorganization of the Office of New Drugs (OND) is part of CDER’s modernization effort, first announced in June 2018 by Janet Woodcock.

The FDA announced the following changes:

• Grouping OND offices and divisions by therapeutic area
• Increasing the number of clinical offices that oversee review divisions from six to eight
• Increasing the number of clinical divisions from 19 to 27, plus six divisions of pharmacology/toxicology, creating divisions with clearer and more focused areas of expertise
• Establishing the new Offices of Program, Administrative, and Regulatory Operations; an Office of New Drug Policy; and an Office of Drug Evaluation Sciences

Read the FDA press release