Future CDER, CBER jurisdictions

An FDA working group has developed a list of the types of products that will be transferred to the Center for Drug Evaluation and Research from the Center for Biologics Evaluation and Research as part of a consolidation announced in September (see BioCentury, Sept. 9, 2002). The following categories of therapeutics that are presently regulated by CBER will be regulated by CDER, according to a memo sent to all FDA staff by the CBER-CDER Product Consolidation Working Group: monoclonal antibodies, cytokines, growth factors, enzymes, interferons (including recombinant versions), and proteins intended for therapeutic use that are extracted from animals or microorganisms.

Also, regulatory and review authority over therapeutic immunotherapies will be transferred to CDER, but "some specifics [are] yet to be worked out," according to the Oct. 28 memo. ...