References
- Grillo-López AJ. The ODAC Chronicles: Part 6a. ODAC’s Structure and Function. Expert Rev. Anticancer Ther. 5(4), 573–577 (2005).
- Grillo-López AJ. The ODAC chronicles: Part 3. The FDA’s philosophy and process for cancer drug evaluation and approval. Expert Rev. Anticancer Ther. 5(1), 1–5 (2005).
- Grillo-López AJ. The ODAC chronicles: Part 4. Hurdles pre- and post- accelerated approval. Expert Rev. Anticancer Ther. 5(2), 197–200 (2005).
Websites
- Guidance for Industry Advisory Committees: Implementing Section 120 of the Food and Drug Administration Modernization Act of 1997 www.fda.gov/cder/guidance/index.htm (Accessed September 2005)
- Transcript: ODAC meeting of July 27, 2004 (Alimta for the treatment of non-small cell lung cancer) Page 202 www.fda.gov/ohrms/dockets/ac/cder04.html#Oncologic (Accessed September 2005)
- Transcript: ODAC meeting of May 3, 2004 (Genasense in combination with dacarbazine for the treatment of Melanoma) Page 154 www.fda.gov/ohrms/dockets/ac/cder04.html#Oncologic (Accessed September 2005)
- Transcript: ODAC meeting of May 3, 2004 (Genasense in combination with dacarbazine for the treatment of Melanoma) Page 174 www.fda.gov/ohrms/dockets/ac/cder04.html#Oncologic (Accessed September 2005)
- Transcript: ODAC meeting of March 3, 2005 (Prostate cancer end points) Page 388 www.fda.gov/ohrms/dockets/ac/cder05.html#OncologicDrugs (Accessed September 2005)
- Transcript: ODAC meeting of May 3, 2004 (Genasense in combination with dacarbazine for the treatment of Melanoma) Page 184 www.fda.gov/ohrms/dockets/ac/cder04.html#Oncologic (Accessed September 2005)