US FDA progresses CBER-CDER moves

The US Food and Drug Administration has completed the third phase ofwork leading to implementation of the transfer of certain product reviews from the Center for Biologics Evaluation and Research to the Center for Drug Evaluation and Research (Marketletters passim).

The first phase identified which products to transfer and the second determined the financial and human resources to transfer to support the work required for these products. The third phase has determined the critical logistical pathways for the consolidation and brings to a close the main planning for transfer of the review functions to the CDER.

The target implementation date for the consolidation is June 30, 2003. Within the next few weeks, the CBER will post on its web site the numbers for all applications being transferred to the CDER and sponsors will be encouraged to check the number listing to ascertain if any of their applications are being transferred.