Food and Drug Administration

Oncologic Drugs Advisory Committee

Pediatric Subcommittee

March 17, 2004


Safety and Extrapolation, Dr. Steven Hirschfeld, MD, PhD, FDA (HTM) (PPT)

Protecting Children in Cancer Research: What Really Matters, Dr. Eric Kodish, MD, Case Medical School (HTM) (PPT)

Legal Responsibilities for Studies Conducted or Supported by HHS, Dr. Michael Carome, MD, DHHS (HTM) (PPT)

FDA Regulations Pertaining to Good Clinical Practice and Clinical Trials, Dr. Steven Hirschfeld, MD PhD, FDA (HTM) (PPT)

Enrollment and Monitoring Procedures for NCI Supported Clinical Trials, Dr. Barry Anderson, MD PhD, National Cancer Institute (HTM) (PPT)

Monitoring the Progress of Trials and the Safety of Participants, Dr. Don Workman, PhD and Dr. Victor Santana, MD, St. Jude Children's Research Hospital (HTM) (PPT)

Microarray Technologies, NIH, Dr. Meltzer (HTM) (PPT)

Advantages and Limitations of Cell Culture Models in Pediatric Drug Development, Dr. Peter Adamson, MD, Children's Hospital of Philadelphia (HTM) (PPT)

Preclinical Models for Developing Therapy for Pediatric Solid Tumors - Uses and Limitations, Dr. Peter Houghton, PhD, St. Jude Children's Research Hospital (HTM) (PPT)

An Integrated Approach to Preclinical/Clinical Drug Deveopment, Dr. Khanna, National Cancer Institute (HTM) (PPT)

Neonatal/Juvenile Animal Safety Studies, Dr. Kenneth Hasting, DrPH, DABT, FDA (HTM) (PPT)

NCI Initiatives to Develop Non-Clinical Models for Pediatric Oncology, Dr. Malcolm Smith, MD, PhD, NIH (HTM) (PPT)