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Sep 19 2011

FDA Reorganizes Oncology and Hematology Divisions

When we are no longer able to change a situation, we are challenged to change ourselves.

Victor Frankl

The FDA recently announced that it is reorganizing three divisions (Hematology Products, Drug Oncology Products, and Biologic Oncology Products) from the Office of Oncology Drug Products into a new office: The Office of Hematology and Oncology Products (OHOP).

This reorganization creates four divisions: Division of Oncology Products 1 (DOP1), Division of Oncology Products 2 (DOP2), Division of Hematology Products (DHP), and Division of Hematology Oncology Toxicology (DHOT).  Importantly, DOP1 and DOP2 will handle reviews for both biologics and drugs.

Click Image for Full Size Table

The FDA also provided the following information on applications that will, or will not, be moving around:

  • Applications Moving to DHP: This list includes hematology applications that will be moving from the former Division of Drug Oncology Products (DDOP) and/or Division of Biologic Oncology Products (DBOP) to Division of Hematology Products (DHP).
  • Applications Moving to DOP1: This list includes solid tumor and supportive care applications that will be moving from the former Division of Biologic Oncology Products (DBOP) to the new Division of Oncology Products 1 (DOP1).
  • Applications Moving to DOP2: This list includes solid tumor applications that will be moving from the former Division of Drug Oncology Products (DDOP) to the new Division of Oncology Products 2 (DOP2).

More information on applications within these divisions can be found here.

This kind of reorganization underlines the importance of documenting all agreements reached with review teams.  If you have made an agreement, say at a formal meeting (ie, Type A, B, or C), ensure that it is documented in the meeting minutes!  Being able to point to minutes in this way can save you a world of headaches.