title: The approval process for hyperthermic intraoperative intraperitoneal chemotherapy.
abstract: OBJECTIVE
  To clarify the requirements for Food and Drug Administration approval in the United States for hyperthermic intraoperative intraperitoneal chemotherapy administration. Also, to review the status of the approval process in Europe.
  
  
  METHODS
  The obstacles to be overcome for approval by the Food and Drug Administration for a new drug approval and for a new device approval were reviewed. Drugs approved in the past were examined for their potential for current application in this technology.
  
  
  RESULTS
  The likelihood that the approval of a heater circulator along with the approval for specific chemotherapy agents for heated intraoperative intraperitoneal chemotherapy was judged to be remote. Rather, the continued use of "homemade heater circulators" and the off-label use of appropriate chemotherapy agents augmented by heat will continue to be the standard of care. The European community currently has several heater circulators approved for hyperthermic intraoperative intraperitoneal chemotherapy administration. These devices have been specifically approved for oncologic indications.
  
  
  CONCLUSIONS
  Continued research and development of heated intraoperative intraperitoneal chemotherapy is necessary. As the requirement for prevention and treatment of the peritoneal surface component of gastrointestinal and gynecologic oncology expands, new investigations into the approval process in the United States will be necessary. Publication of results from institutions pioneering these new treatment strategies will, of necessity, continue.
authors.affiliation: Washington Cancer Institute, Washington Hospital Center, 106 Irving St., NW, Suite 3900, Washington, DC 20010, USA. paul.sugarbaker@medstar.net
authors.forename: P H
authors.initials: PH
authors.lastname: Sugarbaker
authors.forename: L
authors.initials: L
authors.lastname: Clarke
mesh_terms: D000970:Antineoplastic Agents / Q000008:administration & dosage*; D018795:Device Approval; D017277:Drug Approval; D005060:Europe; D006801:Humans; D006979:Hyperthermia, Induced; D007263:Infusions, Parenteral; D010534:Peritoneal Neoplasms / Q000188:drug therapy* / Q000601:surgery*; D014481:United States; D014486:United States Food and Drug Administration
chemical_list: D000970:Antineoplastic Agents