What is Project Renewal
Project Renewal is a public health initiative established by the U.S. Food and Drug Administration (FDA) Oncology Center of Excellence (OCE) that aims to update the labeling information for oncology products by evaluating relevant scientific evidence from published literature.
This initiative established a set of repeatable processes and procedures to inform regulatory decisions for oncology product labeling updates, including potential new indications for use.
Aligned with the FDA’s mission to protect public health, this initiative is an opportunity to transparently collaborate with external stakeholders in the evaluation of scientific evidence to inform clinical decisions and patient care.
Why It Started
Patients and healthcare providers rely on accurate labeling for care and treatment decisions. However, many oncology products on the market today have outdated labeling, despite new information coming available in the post-marketing setting that could support labeling changes, including updated indications for use.
Project Renewal is working to address this public health challenge of outdated product labeling by establishing a set of processes and procedures to inform regulatory decisions for oncology product labeling updates, including potential updated indications for use.
Labeling updates made under Project Renewal could reduce potential risk to patients by providing healthcare providers with updated evidence to inform safe and effective use of oncology products.