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

Industry stakeholders have asked the U.S. Food and Drug Administration to expand the scope of its recent draft guidance on scientifically valid prior knowledge for gene therapies that involve genome editing.

The request specifically calls for the guidance to be extended to cover other types of cell and gene therapies, allowing sponsors to consider a wider range of prior data when developing these products.

The push comes amid a broader FDA focus this week on foreign clinical trial inspections, botanical drug inputs, and a new emergency use authorization for military purposes, highlighting ongoing regulatory attention to emerging therapies.