Industry urges FDA to broaden prior-knowledge guidance for gene and cell therapies

Industry groups have asked the U.S. Food and Drug Administration to broaden its draft guidance on the use of scientifically valid prior knowledge in developing gene therapies that involve genome editing.

The existing guidance defines what prior data sponsors may rely on, but stakeholders say it should also apply to other cell and gene therapy approaches.

If the FDA expands the scope, developers could use a wider range of existing data to support their programs, potentially accelerating development and review.