Cell-Based Products for Animal Use; Guidance for Industry; Availability

The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry #218 (GFI #218) entitled ``Cell-Based Products for Animal Use.'' FDA is aware that many potential veterinary therapies may be produced using cell-based products. GFI #218 describes FDA's Center for Veterinary Medicine's current thinking on cell-based products for animal use that meet the definition of a new animal drug. This guidance is for persons developing, manufacturing, or marketing cell-based products, including ``animal stem cell-based products''.