The Food and Drug Administration issued final guidance June 11 on the agency’s current thinking about how existing regulations apply to the use of cell-based products, including stem cell–based products, in animals. The guidance is directed at facilities and individuals manufacturing and marketing such products.
The guidance clarifies the FDA’s position that the agency has jurisdiction over cell-based products meeting the definition of a new animal drug. Such products generally meet the definition of a new animal drug if they are intended to diagnose, cure, mitigate, treat, or prevent disease in an animal or affect the structure or function of an animal.
At this time, the FDA thinks an approved new animal drug application will be the appropriate regulatory pathway for most such products.
According to the document, the agency recognizes that stem cell–based products that meet certain criteria pose a lower risk to human and animal safety than other stem cell–based products and therefore are a lower enforcement priority. These criteria are that the product is autologous, minimally manipulated, for homologous use, and for use in non–food-producing animals; that the manufacture of the product does not involve combination of the cells with another article, with certain exceptions; and that the finished product is not combined with or modified by the addition of any component that is a drug or device.
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