Zdrowie i gospodarka · 12.06.2015
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".