CBER/CDER Reorganization Template

<table border="1" cellspacing="1" cellpadding="7" width="312"> <tr> <td valign="top" bgcolor="#ffffff"> <br /> <br /> <p> <font face="Times" size="5">CBER/CDER Reorganization Template</font> </p> </td> </tr> <tr> <td valign="top" bgcolor="#ffffff"> <p> <b><i><font face="Times" size="1">FDA has identified four categories of therapeutics currently regulated by the Center for Biologics Evaluation &amp; Research that are to be shifted to the drug center, along with 11 categories that will stay in CBER. Here is the list included in an Oct. 28 agency memo.</font></i></b> </p> </td> </tr> <tr> <td valign="top" bgcolor="#ffffff"> <p> <b><font face="Helvetica Condensed" size="1">Products Moving To CDER</font></b> </p> <ul> <li> <b>Monoclonal antibodies</b> </li> </ul> <ul> <li> <b>Cytokines, growth factors, enzymes, and interferons (including recombinant versions)</b> </li> </ul> <ul> <li> <b>Proteins intended for therapeutic use that are extracted from animals or microorganisms</b> </li> </ul> <ul> <li> <b>Therapeutic immunotherapies (some specifics yet to be worked out)</b> </li> </ul> </td> </tr> <tr> <td valign="top" bgcolor="#ffffff"> <p> <b><font face="Helvetica Condensed" size="1">Products Staying In CBER</font></b> </p> <ul> <li> <b>Monoclonal antibodies, cytokines, growth factors or other proteins when used solely as an ex vivo constituent in a manufacturing process or when solely used as a reagent in the production of a product that is under the jurisdiction of CBER</b> </li> </ul> <ul> <li> <b>Viral-vectored gene insertions (i.e., "gene therapy")</b> </li> </ul> <ul> <li> <b>Products composed of human or animal cells or from physical parts of those cells</b> </li> </ul> <ul> <li> <b>Blood, blood components and fractions, and recombinant versions of typical blood component or fraction transfusion products</b> </li> </ul> <ul> <li> <b>Plasma expanders</b> </li> </ul> <ul> <li> <b>Allergen patch tests</b> </li> </ul> <ul> <li> <b>Allergenics</b> </li> </ul> <ul> <li> <b>Antitoxins, antivenins and venoms</b> </li> </ul> <ul> <li> <b>In vitro diagnostics</b> </li> </ul> <ul> <li> <b>Vaccines</b> </li> <li> <b>Toxoids and toxins intended for immunization</b> </li> </ul> </td> </tr> </table>