The U.S. Food and Drug Administration (FDA) has announced its intention to modernize its approach to the evaluation and support of innovative animal and veterinary products. This move is aimed at enhancing regulatory flexibility, predictability, and efficiency. The recently unveiled Animal and Veterinary Innovation Agenda has the objective to foster product development and establish intelligent, risk-based regulatory methods for modern animal and veterinary products. These steps are intended to keep the agency aligned with ongoing scientific and technological advancements while ensuring the availability of safe and effective products in the market.
This new agenda encompasses a variety of products, including novel food ingredients designed to improve nutritional efficiency and production in the animal’s digestive system. It also covers animal biotechnology products like animal cell- and tissue-based products (ACTPs) and deliberate genomic alterations (IGAs) in animals, as well as cell-cultured animal food ingredients, among others. In addition, the agenda is designed to encourage the development of products that address unmet needs in both human and animal health, particularly focusing on the absence of specialized therapeutics approved for use in animals.
The FDA is actively planning to review and adjust its animal and veterinary product evaluation programs and processes, taking into account the diverse range of products created through innovative technologies. For instance, the agency is collaborating with Congress to establish new legislative authority that will introduce novel approval pathways for zootechnical animal food substances, specifically novel food ingredients that function within the animal’s digestive system to enhance qualities such as feed efficiency, waste reduction, or a decrease in pathogens found in food products derived from the animal.
