cGxP

Consulting

 

 

Products to Be Transferred From CBER to CDER

The FDA’s plan to transfer review of biologic therapeutic products from CBER (Center for Biologics Evaluation and Research) to CDER (Center for Drug Evaluation and Research) is being implemented by the “consolidation working group”.

 

The working group, co chaired by Dr. Murray Lumpkin, Senior Associate Commissioner, and Dr. Theresa Mullin, Associate Commissioner for Planning, has released the FDA’s decision to transfer the oversight of four product categories from CBER to CDER.  Those categories are:  cytokines, enzymes, growth factors, interferons, and recombinant versions of the following products:  monoclonal antibodies; therapeutic proteins of biological origin; and therapeutic immunotherapies.

 

There are other product categories which the FDA will move in the future but for now will remain under CBER’s review.  Those products are:  allergenic products and allergen patch tests;  antitoxins and antivenins; blood and plasma products;  cell and cell-derived products;  gene therapy products;  in vitro diagnostic products;  vaccines;  cytokines, monoclonal antibodies or other proteins when their sole use is as a reagent or as an “ex vivo constituent” in a CBER-regulated product’s production.