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public workshop that will examine the challenges and opportunities to update labeling for generic oncology drugs with outdated labels (i.e., labels that are inconsistent with current data and use in the oncology community).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· Opportunities for collaboration to revise outdated oncology drug labels.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.