Cheers to the FDA for the new structure it is giving to oncology drug review ! In a move that would be expected to strengthen transparancy and clarity, the FDA today announced chances in the drug center's Oncology (cancer drug) office.
We are going to need to learn some new phrases like OHOP, DHP, DOP1 DOP2 and DHOT. What the FDA has recognized is that cancer medicines and treatment approaches have become more complex and actually require a disease specific kind of approach.
The Center for Drug Evaluation and Research (CEDER) Office of Oncology Drug Products is now to be called the Office of Hematology and Oncology Products (OHOP). Change will also happen for the three existing divisions called Division of Hematology Products (DHP), Division of Drug Oncology Products (DDOP) and Division of Biologic Oncology Products (DBOP).
The old divisions will now expand into 4 new ones: Division of Hematology Products (DHP), Division of Oncology Products 1 (DOP1), Division of Oncology Products 2 (DOP2), and Division of Hematology Oncology Toxicology (DHOT). What this means is that the FDA is now more aligned with the National Cancer Institute, academic programs and leading cancer centers in structure.
DOP1 and DOP2 will be the FDA review for cancer treatments for solid tumors and DHOT will review nonclinical pharmacology and toxicology as it relates to cancer therapies. While timely revieew of cancer treatments will still be a challenging task for the 130 OHOP employees, the FDA expects to gain some efficiencies from the new structure.