FDA Aims to Improve Accelerated Approval Process for Gene Therapies and Oncology Clinical Trials

The FDA has issued draft guidance aimed at improving oncology clinical trials for accelerated approval applications. The guidance discusses the design of clinical trials and ways to improve the data available at the time of accelerated approval and reduce clinical uncertainty for patients by initiating postmarketing confirmatory studies in a timely manner. The draft guidance also provides considerations for sponsors to determine the adequacy of single-arm studies to support an application.