Food and Drug Administration requirements for approval of new anticancer drugs

Cancer Treat Rep. 1985 Oct;69(10):1155-9.


For approval of new drugs, the law requires a minimum of two independent well-controlled studies for each indication. The preferred study design is prospective, randomized, and comparative. The use of historical controls, while sometimes acceptable, must be justified. A favorable effect on survival and/or quality of life is generally required for approval. The study of cancer drugs in combination presents problems which are discussed. Drug firms are strongly urged to discuss the protocols with the Food and Drug Administration prior to initiating phase III comparative studies to be used for approval of the drug.

Publication types

  • Comparative Study

MeSH terms

  • Antineoplastic Agents / therapeutic use*
  • Antineoplastic Combined Chemotherapy Protocols / therapeutic use
  • Clinical Trials as Topic / standards*
  • Humans
  • Legislation, Drug*
  • Neoplasms / drug therapy*
  • Neoplasms / mortality
  • Prospective Studies
  • Random Allocation
  • United States
  • United States Food and Drug Administration*


  • Antineoplastic Agents