The American Association for Cancer Research (AACR) is working with the U.S. Food and Drug Administration (FDA) to advance the FDA’s public health initiative called Project Renewal. Launched in October 2018 by the FDA’s Oncology Center for Excellence (OCE), Project Renewal has an ambitious goal to update labeling information for long-standing off-patent oncology drugs by evaluating accumulated scientific evidence from published research literature. To facilitate this opportunity, the FDA, through Project Renewal, has engaged Deloitte (a multinational professional services network) and the AACR to seek strategic scientific advice and perspective, enhance the scientific integrity of a repeatable process, and gain insights into the evidence evaluation process.
About Project Renewal
FDA labeling is a central source of scientifically rigorous information on the safe and effective use of anticancer diagnostic and therapeutic products. Over time, labeling can become outdated, as new information becomes available in the postmarketing setting. The FDA has a long-standing commitment to supporting generic drug development and competition, which can help reduce prices, improve access, and benefit public health. Project Renewal has been initiated to advance the FDA’s goal to keep generic oncology product labeling up-to-date on a more frequent basis. In its first year, Project Renewal has developed a set of repeatable processes and procedures to evaluate evidence from published literature to inform regulatory decisions for updated product labeling of older oncology drugs.
Deloitte and the AACR aim to support Project Renewal through creating an objective, repeatable process to engage the oncology research, education, and care community. Project Renewal will leverage the AACR’s scientific expertise and deep network of basic and clinical cancer researchers to provide valuable insights into the evidence-evaluation process. Through this collaboration, the AACR sees a long-term benefit to the oncology community by providing cancer scientists, clinicians, and trainees with the unique experience of interacting with the FDA to better understand how the FDA evaluates evidence and to allow the oncology community to inform potential labeling updates.
Utilizing the collective wisdom and insights of health-care providers devoted to advancing cancer research, this public health initiative hopes to make available the most up-to-date information to patients and oncology professionals through FDA product labeling while fostering engagement between the FDA and members of the oncology community.