FDA offers guidance on donors and manufacturing for veterinary cell therapies
by Katie Pfaff
Under the FD&C Act, the US Food and Drug Administration shared two draft guidance documents on the current good manufacturing practice requirements (CGMP) for animal therapies using ACTPs, or animal cells, tissues, and cell- and tissue-based products. The guidance is not yet finalized, and the FDA is seeking public comment until November 22, 2021.
"ACTPs have the potential to make significant changes in how we treat diseases and may provide novel therapies for unmet therapeutic needs of animals. We want to support manufacturers in the safe production of these promising products," said Dr. Janet Woodcock, acting commissioner of the FDA. "It is important to note that the FDA is not imposing any new requirements on the manufacturers of ACTPs with these new draft guidance documents. These draft guidance documents, if finalized, are intended to assist manufacturers by providing product-specific recommendations that will help developers of these products meet existing FDA manufacturing requirements. Our goal is to help manufacturers be successful in their efforts to develop innovative products that can benefit animal health."
The guidance, created under the Center for Biologics Evaluation and Research rules, defines ACTPs, donor regulations, and products deemed “new animal drugs.” The two guidance documents are: #253, "Good Manufacturing Practices for Animal Cells, Tissues, and Cell- and Tissue-Based Products" and #254, "Donor Eligibility for Animal Cells, Tissues, and Cell- and Tissue-Based Products"
Among the guidance information, FDA also suggests that manufacturers contact the agency early in development and maintain communication. "The FDA is seeking to improve transparency by engaging early in the development process and informing industry of our draft recommendations now, while the industry is still taking shape, as we are receiving applications seeking approval of ACTPs for use in animals," said Dr. Steven Solomon, director of the FDA's Center for Veterinary Medicine. "As part of our commitment to fostering the development of innovative products in the most streamlined and efficient manner possible, we're encouraging the ACTP industry to take advantage of our Veterinary Innovation Program, which is designed to assist product developers generate the appropriate data needed to support a new animal drug application."
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