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Project Information

Project Information

Updating Labels for Generic Oncology Drugs: A Workshop

Project Scope:

An ad hoc committee will plan and host a 1.5-day public workshop that will examine the challenges and opportunities to update labeling for generic oncology drugs with outdated labels (i.e., labels that are inconsistent with current data and use in the oncology community). The workshop will feature invited presentations and panel discussions on topics that may include:

·      Current FDA guidelines regarding the quality and quantity of evidence required to support claims of safety and effectiveness in new drug applications.

·      Current use of published literature and data from clinical trials to guide clinical use of generic oncology drugs.

·      Potential criteria and sources of data to guide decision making for generic label updates on indications, dosing, and adverse events.

·      Approaches for addressing specific gaps in labeling, such as for specific patient populations (e.g., pediatric), and for cross-labeling combination therapies.

·      Opportunities for collaboration to revise outdated oncology drug labels.

The committee will develop the agenda for the workshop sessions, select and invite speakers and discussants, and moderate the discussions. A proceedings of the presentations and discussions at the workshop will be prepared by a designated rapporteur in accordance with institutional guidelines.

Status: Current

PIN: HMD-HCS-18-04

RSO: Nass, Sharyl


Health and Medicine
Policy for Science and Technology

Geographic Focus:

Committee Membership

Harold L. Moses - (Chair)
Amy P. Abernathy
Andrew B. Bindman
S. G. Eckhardt
Susan Halabi
R. D. Harvey
Ishmael Jaiyesimi
Richard L. Schilsky
Steven Sun
Josephine M. Torrente
Kathy Warren


Event Type :  

Description :   

The National Cancer Policy Forum will hold a public workshop on Tuesday, March 26th, 2019 on Updating Labels for Generic Oncology Drugs. This workshop will convene expert stakeholders to discuss the challenges and opportunities to update generic oncology drugs labels that are inconsistent with the current evidence base and use in clinical practice. Discussions will focus primarily on considering the potential data sources and evidence requirements for adding new indications to outdated labels, including indications for select patient populations (such as pediatric oncology).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

The agenda and registration information will be forthcoming.

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.


Registration for Online Attendance :   

Registration for in Person Attendance :   

If you would like to attend the sessions of this event that are open to the public or need more information please contact

Contact Name:  -
Contact Email:  -
Contact Phone:  -

Supporting File(s)
Is it a Closed Session Event?

Publication(s) resulting from the event:




No data present.