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Project Renewal

Project-Renewal-LOGO

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 However, many oncology products on the market today have outdated labeling, despite new information coming available in the post-marketing setting that could support labeling changes, including updated indications for use.

Project Renewal is working to address this public health challenge of outdated product labeling by establishing a set of processes and procedures to inform regulatory decisions for oncology product labeling updates, including potential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 are intended to provide updated evidence to inform safe and effective use of oncology products.

KEY GOALS

Develop Repeatable Process, represented by arrows in a full circle, to evaluate scientific evidence and determine whether labeling updates are needed

Develop Repeatable Processes

to evaluate scientifc evidence and determine whether labeling updates are needed

Use Available Published Data, represented by magnifying glass examining an open book, to research off label uses and develop a method to update existing labels

Use Published Data

to research off-label uses and develop a method to update existing labels

Collaborate with Oncology Community, represented by a circular icon of a crowd of diverse individuals, to increase public awareness of the FDA and enhance FDA staff experiences

Engage with Oncology Community

to increase transparency of FDA processes and encourage collaboration

Foster Educational Experiences, with a profile of a person’s head with a lightbulb inside, for Oncology Fellows to learn about the FDA’s mission and regulatory processes

Foster Educational Experiences

for Oncology Fellows to learn about FDA's mission and regulatory processes

 

ADDITIONAL INFORMATION