Hypatia Wins Contract to Repurpose Cancer Drugs For The FDA Oncology Center of Excellence
The U.S. Food and Drug Administration (FDA) Oncology Center of Excellence (OCE) launched Project Renewal to update labeling information for long-standing off-patent oncology drugs.
This drug repurposing work will address:
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.
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.
