Updating Labels for Generic Oncology Drugs: A Workshop
The National Cancer Policy Forum held a public workshop on Tuesday, March 26th, 2019 on Updating Labels for Generic Oncology Drugs. This workshop convened expert stakeholders that discussed the challenges and opportunities to update generic oncology drugs labels that are inconsistent with the current evidence base and use in clinical practice. Discussions focused primarily on considering the potential data sources and evidence requirements for adding new indications to outdated labels, including indications for select patient populations (such as pediatric oncology).
Planning Committee Members:
• Harold L. Moses, (Chair), Vanderbilt-Ingram Comprehensive Cancer Center
• Amy P. Abernethy, Flatiron Health
• Andrew B. Bindman, University of California San Francisco
• S. Gail Eckhardt, The University of Texas at Austin
• Susan Halabi, Duke University School of Medicine
• R. Donald Harvey, Emory University Winship Cancer Institute
• Ishmael Jaiyesimi, William Beaumont Hospital
• Richard L. Schilsky, American Society of Clinical Oncology
• Steven Sun, Janssen Inc.
• Josephine M. Torrente, Hyman, Phelps & McNamara, P.C.
• Kathy Warren, National Cancer Institute
This project is sponsored by the Food and Drug Administration and is being conducted under the auspices of the National Cancer Policy Forum, in collaboration with the Forum on Drug Discovery, Development, and Translation.