FDA Realignment Strengthens New Drug Approval and Evaluation Capabilities
As a result of new regulatory responsibilities and evolving drug development activity in certain therapeutic areas, the U.S. Food and Drug Administration (FDA) today announced a realignment within its Center for Drug Evaluation and Research’s (CDER) Office of New Drugs (OND), effective March 15, 2010.
CDER’s Office of New Drugs is known as a “super office,” under which there are currently six Offices of Drug Evaluation (ODEs). Each of these offices has several divisions, whose staff members are responsible for reviewing and evaluating investigational new drug applications (INDs), new drug applications (NDAs), and biologics license applications (BLAs) for drug and biologic products intended to diagnose or treat specific diseases and conditions. The Agency has realigned various review functions to enhance the logical groupings of applications within each ODE and division and to achieve a more balanced workload across OND review divisions.
In some cases, the realignment has required reassignment of current INDs, NDAs and BLAs to newly organized divisions within the same ODE, and in others the applications have been reassigned to a newly organized division in a different ODE. However, since the majority of FDA staff members evaluating those applications have been concurrently reassigned to these divisions, FDA expects minimal impact of this realignment on the review of current applications. Applications already submitted to FDA will retain their current application numbers and due dates. Please see Applications that have been reassigned as a result of this realignment.
Specific changes related to the OND realignment are as follows: rheumatology products and review staff will move from the Division of Anesthesia, Analgesia, and Rheumatology Products, now newly named the Division of Anesthesia and Analgesia Products, to the Division of Pulmonary and Allergy Products, now newly named the Division of Pulmonary, Allergy, and Rheumatology Products. Both of these newly named and realigned divisions remain in ODE II. Medical imaging products and review staff have moved from the Division of Medical Imaging and Hematology Products, now newly named the Division of Hematology Products, to a newly formed division called the Division of Medical Imaging Products. The Division of Hematology Products remains in the Office of Oncology Drug Products. The newly formed Division of Medical Imaging Products is under the former Office of Nonprescription Products, now newly named the Office of Drug Evaluation IV (ODE IV).