REGULATORY CORNER

Those of us working in drug development for several years have likely, at one time or another, focused on the requirements for the development of a combination product. They are listed in 21CFR300.50 Fixed-combination prescription drugs for human use; a regulation dated March 27, 1975 and amended on January 5, 1999. FDA also issued a guideline in 2013, Codevelopment of Two or More New Investigational Drugs for Use in Combination (the 2013 Codevelopment Guidance) that further expands on the information in the regulation.

In August 2025, FDA issued the draft guidance, Approaches to Assessment of Overall Survival in Oncology Clinical Trials. This guidance is based in part on discussions held at a joint FDA, American Association for Cancer Research (AACR), and American Statistical Association (ASA) public workshop held in July 2023. It also puts into writing feedback that I have received from the Agency on oncology clinical trials and guidance that I have related to our oncology clients.