FDA Realignment of the Office of New Drugs within CDER
Effective March 15, 2010, FDA has realigned certain review divisions in the Center for Drug Evaluation and Research (CDER) to better group similar investigational, new drug, and biologics licensing applications. Included in the realignment are medical imaging applications, which have moved from the Division of Medical Imaging and Hematology Products to the new Division of Medical Imaging Products, while hematology applications are now in the Office of Oncology Drug Products in the new Division of Hematology Products. In addition, rheumatology applications have moved from the Division of Anesthesia, Analgesia, and Rheumatology Products to the new Division of Pulmonary, Allergy, and Rheumatology Products. Applications for products to treat the pain of rheumatological diseases, rather than to treat the underlying disease process, will remain in the Division of Anesthesia and Analgesia Products. The FDA has posted a listing of all current applications that have been reassigned.
