FDA issues draft guidance outlining data flexibilities for cell and gene therapy developers

The FDA released a draft guidance from its Center for Biologics Evaluation and Research (CBER) that clarifies how developers of cell and gene therapies can use existing data and prior knowledge in various stages of product development.

The guidance describes the types of clinical, nonclinical and manufacturing information that may be leveraged to support safety and efficacy assessments, potentially reducing the need for redundant studies.

By outlining these flexibilities, the agency aims to streamline development timelines and lower costs while maintaining regulatory standards, offering a clearer path for companies advancing novel therapies.