A collaboration between FDA’s Oncology Center of Excellence
and the American Association for Cancer Research
What is Project Livin’ Label?
Oncology product labels contain essential information needed for their safe and effective use. However, many are unfamiliar with the product labels, what information is contained in them, and how to use them. Project Livin’ Label is an educational initiative that aims to foster broad understanding of the associated oncology product label and increase awareness of recent oncology product FDA approvals in the cancer community.
Using oncology product labeling as a road map, the FDA’s Oncology Center of Excellence (OCE) will guide discussions between an FDA reviewer, a clinical trial investigator, a patient, and the company on the backstory of the oncology product development and FDA review process.
Join us as the OCE highlights select cancer therapeutics clinical development programs and releases knowledge about the oncology products’ clinical journey from development to approval.
Introduction to Project Livin’ Label
Who Is the Target Audience?
Our primary audience includes physicians, other health care providers, cancer survivors, patients, advocates, families, industry, and others who are seeking to better understand cancer therapy development. For health care professionals, the AACR is providing Continuing Medical Education (CME) credit.
How Will FDA Select Which Products to Highlight?
The FDA is selecting products based on certain attributes of their development program. These attributes will illustrate key issues in the development and review of each oncology product, and details will be discussed in each webinar.
Project Livin’ Label is an educational initiative. Project Livin’ Label is not intended to promote any one oncology product over another, nor does it constitute an endorsement by FDA or AACR for use of that oncology product.
Why Are FDA and AACR Working Together?
The OCE and AACR have complementary missions. Each organization relies on the expertise of hematologists, oncologists, and scientists that are well-trained on the fundamentals of oncology products. This educational collaboration will help to provide insight and transparency into the approvals of selected FDA oncology products.