The U.S. Food and Drug Administration (FDA) will reorganize the Office of New Animal Drug Evaluation (ONADE) within the Center for Veterinary Medicine (CVM) into two separate offices that will handle pre-market evaluation of originator animal products and generic drugs. The reorganization implementation will take place October 20.
The realignment of ONADE into the Office of New Animal Product Evaluation (ONAPE) and the Office of Generic Animal Drugs (OGAD) comes at a critical time in the animal drug review program. This reorganization will enable ONAPE to continue to build capacity to support review of new and innovative technologies, which the center sees as the future of animal agriculture and animal health products.
At the same time, the agency has seen unprecedented growth in the generic animal drug review program over the past 8-10 years. Standing up OGAD as an independent office will provide for concentrated focus for the generic animal drug program and maximize the program’s effectiveness.
The reorganization also includes certain changes to CVM’s Office of Management (OM). The records and information management team, which resided in ONADE, will become part of OM’s business informatics staff. Additionally, the new financial management staff will be created by combining the budget planning and evaluation staff and program and resource management staff functions and resources under one staff director.
