The agenda is a step toward the FDA modernizing its approach to evaluating and supporting creating innovative animal and veterinary products.
The FDA announced that it has launched the Animal and Veterinary Innovation Agenda (AVIA) as a way to modernize the way the FDA evaluates and supports the development of innovative animal and veterinary products. The guidelines break for a list of 4 objectives and details that will support actions by the Center for Veterinary Medicine (CVM) to strengthen product development and put into place smart, risk-based approaches as a way to regulate modern animal and veterinary products.
The FDA is planning to go through its animal and veterinary product review programs and projects to reassess and adjust them as needed to account for the diversity of developed products using innovative technologies. According to the organizational release,1 the agenda will apply to products such as novel food ingredients, animal biotechnology products and tissue-based products (ACTPs), intentional genomic alternations (IGAs) in animals, cell-culture animal food ingredients, and more.
“Novel technologies brought to the forefront in recent years have the potential to set a new course for the way veterinarians and food producers support human and animal health,” said Robert M. Califf, MD, FDA Commissioner, in the release.1 “The FDA is committed to helping developers bring products that enhance public health, animal health, and food production to market while providing consumers with confidence that they meet the FDA’s high standards.”
“This comprehensive agenda is intended to accelerate smart regulatory pathways and enhance continued public confidence in the FDA’s regulation of these products while avoiding unnecessary barriers to future industry advancements,” he continued.
By modernizing the product review procedures, this will allow the FDA to focus on specific questions that are being raised by upcoming products that are utilizing new and emerging technologies as well as provide clarity and predictability to its review process.
The new agenda will also expand the FDA’s popular Veterinary Innovation Program (VIP), known as VIP Plus, so that it includes more features for developers of ACTPs and IGAS about their interactions with the FDA. VIP Plus is planning to launch later this year with new tools that will help product development and improve the efficiency of the FDA’s review process by targeting data requirements to answer specific risk questions for products.1 The agency will also be providing advanced computational tools to assist developers and reviews to break down complex genomic data.
“This document is a natural progression of CVM conversations with the other FDA Centers; federal, state, local, and tribal partners; foreign counterparts; the industries we regulate; and the research community about how CVM contributes to maximizing One Health benefits from this era of innovation across a wide range of applications. This will bolster CVM’s ability to contribute to US Government One Health efforts. Today’s AVIA is an initial catalog of CVM’s current and intended actions toward this goal – I intend to further revise, refine, and add to the listed actions as this conversation continues,” expressed Tracey Forfa, JD, MDiv, director for CVM.2
The agenda will also have plans to invest in data modernization, revise its vision for CVM’s science program, and scan for upcoming technologies and developments that can pave the way for new kinds of animal and veterinary products. The FDA will also publicly track progress and work with federal, tribal, and state partners to gain public input on certain parts of the agenda and will implement a scientifically sound, risk-based regulatory approach that will push innovation in tangent with protecting public health.1