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Editorial

The ODAC Chronicles: Part 3. The FDA’s philosophy and process for cancer drug evaluation and approval

Pages 1-5 | Published online: 10 Jan 2014

References

  • Grillo-López AJ. The ODAC Chronicles: Part 1. My first ODAC experience. Expert Rev. Anticancer Ther.4(5), 579–582 (2004).
  • Coiffier B, Lepage E, Briére J et al. CHOP chemotherapy plus rituximab compared with CHOP alone in elderly patients with diffuse large B-cell lymphoma. N. Engl. J. Med.346, 235–242 (2002).
  • Grillo-Lopez AJ. Rituximab: the first decade (1993–2003). Expert Rev. Anticancer Ther.3(6), 767–779 (2003).
  • Grillo-López AJ. Rituximab: clinical development of the first therapeutic antibody for cancer. In: Applications of Pharmaceutical Biotechnology, A Comprehensive Textbook. Kayser O, Müller R (Eds), Wiley-VCH Verlag, Weinheim, Germany, Chapter 12, 205–221 (2003).
  • Grillo-López AJ. Cancer therapies crisis in the USA. Expert Rev. Anticancer Ther.3(5), 579–582 (2003).
  • Grillo-López AJ. The ODAC chronicles: Part 2. Statistics and clinical medicine in the USA: the triumph of science over art? Expert Rev. Anticancer Ther.4(6), 941–944 (2004).
  • Grillo-López AJ. Monoclonal antibodies in the treatment of hematologic malignancies. Curative therapies for NHL: a question of time! A special issue of Curr. Pharm. Biotechnol.2(4) (2001).
  • Farrell AT (FDA/CDER/DODP). Regulatory Considerations for End Points. Oral/slide presentation and handout at the 16 December, 2003 ODAC meeting.
  • Johnson JR, Williams G, Pazdur R. End points and United States Food and Drug Administration approval of oncology drugs. J. Clin. Oncol.21, 1404–1411 (2003).

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