July 31, 2014
Today, the U.S. Food and Drug Administration issued a draft Guidance for Industry describing the agency’s current thinking on cell-based products for animal use that meet the definition of a new animal drug. The draft guidance is directed at facilities and individuals manufacturing and marketing such products for animal use.
FDA is aware that many potential veterinary therapies may be produced using cell-based products. Developers of such products for animal use have asked how the agency intends to regulate these products.
Cell-based products that meet the definition of a new animal drug are subject to the same statutory and regulatory requirements as other new animal drugs. A cell-based product, including an animal stem cell-based product, that is intended to diagnose, cure, mitigate, treat, or prevent disease in animals or is intended to affect the structure or function of the animal generally meets the definition of a new animal drug. To be legally marketed, a new animal drug requires an approved or conditionally approved new animal drug application (NADA) or index listing. At this time, FDA thinks an approved NADA will be the appropriate regulatory pathway for most cell-based products.
This draft guidance:
- Clarifies FDA’s position that it has jurisdiction over cell-based products meeting the definition of a new animal drug;
- Clarifies FDA’s current thinking on how existing regulations apply to cell-based products;
- Establishes a common vocabulary, including definitions, for cell-based products;
- Establishes a risk-based category structure for cell-based products; and
- Encourages industry to communicate and interact with FDA early in product development.
FDA is seeking public comment on this draft guidance through September 30, 2014.