Food and Drug Administration

Oncologic Drugs Advisory Committee

December 16, 2003

Slides

Regulatory Considerations fo Endpoints, Dr. Ann Farrell, MD, FDA (HTM) (PPT)

Endpoints for Past Approvals, Ramzi Dagher, FDA (HTM) (PPT)

Selected Issues on Oncology Trial Design, Dr. Grant Williams, MD, FDA (HTM) (PPT)

Questions, Dr. Richard Pazdur, MD, FDA (HTM) (PPT)

Presentation by Dr. Martin Cohen, MD (HTM) (PPT)

Presentation by Dr. Paul Bunn, MD (HTM) (PPT)

Patient Reported Outcomes as Endpoints in Lung Cancer and Thoracic Malignancies, Dr. Richard Gralla, MD, New York Lung Cancer Alliance (HTM) (PPT)

Open Public Hearing

Astrazeneca Oncology (HTM) (PDF)