© 2004 ASCO/Todd Buchanon
The FDA is consolidating several divisions into a single Office of Oncology Drug Products (ODP) that will oversee drugs and certain therapeutic biologics targeted at cancer, as well as drugs and biologics for medical imaging. The office, which should be fully operational by April 2005, will be housed in the Center for Drug Evaluation and Research (CDER). The ODP will have three review divisions, but exactly how staff, products, and responsibilities will be allocated is still unclear. A national search for an ODP director will begin shortly with advertisements in oncology journals.
"A major stimulus for developing this new office was the transfer of review of many therapeutic biologic products from CBER (the Center for Biologics Evaluation and Research) to CDER" last summer, according to John K. Jenkins, director of CDER's Office of New Drugs. "A large number of the products transferred were biologics...