We, the FDA’s Center for Veterinary Medicine (CVM), recognize that many universities conduct research and participate in the development of animal cells, tissues, and cell- and tissue-based products (ACTPs). Many of these ACTPs meet the definition of a new animal drug.1
We recently issued two new draft guidance documents regarding the determination of donor eligibility and good manufacturing practices for ACTPs. In June 2015, we issued final guidance document # 218, “Cell-Based Products for Animal Use,” about the jurisdiction and regulation of cell-based products for animal use. In final guidance # 218, the FDA stated that when an ACTP is regulated by the FDA as a new animal drug, the person conducting the ACTP research and development must comply with applicable regulatory and statutory requirements for new animal drugs. These draft guidance and final guidance documents describe your responsibilities when you conduct ACTP research and give you information about the requirements for FDA approval before marketing your ACTP.
Soon after publishing guidance #218, we reached out in a letter to stakeholders informing them about the guidance, which includes the FDA’s current thinking on responsibilities when conducting research on ACTPs. This letter and guidance #218 reminded those involved in researching, manufacturing, and marketing cell-based products for animal use that such activities may require an investigational new animal drug exemption (INAD) or an approved new animal drug application (NADA). We encourage you to look at these materials.
In the new draft guidance document #253, “Good Manufacturing Practices for Animal Cells, Tissues, and Cell- and Tissue-Based Products," we provide you with information about our recommendations for meeting good manufacturing practices (GMPs) when you manufacture an ACTP. These GMPs include early manufacturing steps such as recovery of cells or tissues from a donor as well as initial processing steps that may be performed in a veterinary facility. The draft guidance also provides our recommendations about aspects of manufacturing that are unique to ACTPs.
In the second draft guidance document # 254, “Donor Eligibility for Animal Cells, Tissues, and Cell- and Tissue-Based Products,” we describe what you should consider when evaluating whether your donor is eligible. We explain how a risk-based approach can help you ensure that relevant disease agents are absent. Also, we identify the information you should submit to CVM in support of each donor used in the manufacture of an ACTP. At any time, we encourage your comment on these new draft guidance documents.
The concepts and principles in these guidance documents are consistent with the FDA’s Center for Biologics Evaluation and Research’s (CBER’s) regulations (21 CFR 1271 subparts C and D) and associated guidance documents for human cells, tissues, and cellular and tissue-based products.
We also announced the Veterinary Innovation Program (VIP) for ACTPs. This program includes a number of potential benefits for sponsors of ACTPs when seeking FDA approval of a new animal drug application. The goals of the program are to reduce uncertainty in the regulatory process, encourage development and research of innovative products, and achieve an efficient and predictable pathway to approval for ACTPs.
The FDA also recently announced a listing of clinical field studies that are investigating ACTPs in veterinary patients. The webpage provides animal owners, veterinarians, researchers and the public with information on clinical field studies investigating the use of ACTPs in veterinary patients. Clinical field studies evaluating ACTPs are listed on the webpage when the sponsor has provided specific information to the FDA about the study and the sponsor consents to having their study information listed on the webpage. We encourage you to conduct research and develop data that supports approval of ACTPs and to request to list your clinical studies on the FDA’s webpage.
We encourage you to review the information and references provided in this letter and share this letter with others in your institution responsible for the research, manufacture, and clinical application of ACTPs. If you have any questions about your responsibilities or if you need additional information, please contact AskCVM@fda.hhs.gov.
We also welcome your comments on the draft guidance documents issued today. The FDA is accepting public comments on both draft guidance documents until Nov. 22, 2021 so that we may consider comments before issuing final guidance documents; however, comments on guidance documents are welcome at any time. Later this year, CVM will post a pre-recorded webinar to discuss the guidance documents in more detail for interested stakeholders.
FDA’s Center for Veterinary Medicine
1 In general, cell-based products meet the definition of a new animal drug, if among other things, those products are intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in animals, or are intended to affect the structure or any function of the animal. See the Food, Drug, and Cosmetic Act, section 201(g)(1).