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  5. Animal and Veterinary Innovation Agenda - Looking Ahead
  1. Animal and Veterinary Innovation Agenda

Animal and Veterinary Innovation Agenda - Looking Ahead

Innovation is a continual and iterative process. The FDA Animal and Veterinary Innovation Agenda aims to improve existing programs and develop new programs to spur innovation. Some actions FDA intends to take to support these goals are highlighted below.

One Health Code of Practice

In conjunction with our agency partners, FDA is developing specific, measurable actions to adapt the center’s operational practice, risk prioritization, and strategic planning to integrate human, animal, and environmental scientific areas of focus to address complex public health problems. More intentional scientific and regulatory collaboration across disciplines, with other FDA centers and offices, with the FDA’s federal and state co-regulators and with other partners will build a more effective workforce, allow for discovery of new opportunities, and minimize hand-off gaps between partners. FDA is dedicated to being a model for leaving behind silos in favor of agile, systems-based approaches. 

ADVANce Program

FDA is in the process of forming the ADVANce Program –Accelerating the Development of Veterinary and Animal Needs – designed, in part, based on the success of sister programs at the FDA such as the Accelerating Rare Disease Cures Program and the Oncology Center of Excellence. This program will establish partnerships with the veterinary medical community, universities, and other partners to work with CVM to address the most critical priorities. The program’s activities will include the following: 

  • Identify and develop proposals to address priority unmet veterinary medical needs; 
  • Identify and develop proposals to mitigate potential economic, production, or other market barriers; and 
  • Examine the use of real world and translational data to support novel ways to meet regulatory endpoints and potential changes to regulatory pathways for these products.

Animal Food Innovation Hub

FDA intends to establish an Animal Food Innovation Hub in the Office of Surveillance and Compliance. FDA has long offered pre-submission conferences to exchange information and ease the application process across the regulated product areas. These early meetings help sponsors design and conduct studies that will provide appropriate data to meet the FDA requirements for approval and provide predictability into the review process. Food additive petitioners and those submitting GRAS notifications are historically less likely to seek a pre-submission conference than New Animal Drug sponsors. A single point of entry with dedicated resources is intended to encourage the animal foods sector to seek a pre-submission conference to address any uncertainties in the application process.

Chemical Contamination Playbook

We’re developing a Chemical Contaminant Playbook to detail to how we can respond to situations where animals – especially herds and flocks that are part of our food supply – may have been exposed to contaminants, particularly when these incidents involve contaminants that lack safety data or validated testing methods. FDA and our partners have long worked together to respond to these types of incidents, and, based on gained experience reflected in the playbook, can give stakeholders new insight and confidence in working with Federal partners. FDA will also explore a consistent framework for supporting co-regulators such as EPA, USDA, tribal organizations, states, and territories in circumstances where these contamination events cross jurisdictions.

Science Visioning

FDA is embarking on a process to develop a clearly defined vision for the Center for Veterinary Medicine’s (CVM’s) scientific and research functions, to deliver upon the goals contained in this innovation agenda and ensure its scientific expertise can have the greatest impact on animal and human health. CVM is conducting this process in collaboration with other scientific offices across the FDA. 

Innovation Exploration Task Force

We are exploring the formation of an Innovation Exploration Task Force, which will work across the center and in collaboration with FDA's Office of the Chief Scientist to develop and implement methods to monitor emerging technologies across sectors, including biomedical products and novel food ingredients for both animals and humans, that can impact FDA’s regulatory work in products for animals. 

FDA will seek input from partners on new technologies and methods that may lead to new kinds of products or new kinds of data about products coming to the FDA for approval. This early awareness can give FDA the lead time to address, from a regulatory science and policy perspective, the utility of FDA’s current pathways or methods for these products. By assessing the risks and opportunities associated with a given emerging technology, FDA will be better positioned to have appropriate regulatory frameworks in place before these products come to the center for review.

Supply Chain Monitoring

Taking a page from lessons learned during the pandemic, we’re proactively monitoring and responding to potential supply chain disruptions and shortages. Events that create animal food and drug product shortages can affect multiple distribution chains and end-user populations. In recent years we have worked with industry partners to encourage proactive communications with FDA about potential shortages, and continuing to move towards a coordinated cross-FDA response will improve our efficiency in addressing problems and mitigating negative outcomes.

Data Modernization

CVM is working with the Office of Digital Transformation on an enterprise-wide effort to pull data out of locked systems that limit their utility and into a secure data lake environment. The ability to access and utilize data from various internal and external sources will allow CVM to analyze large data sets to inform on-demand, data-driven decisions, and to more effectively respond to human and animal health emergencies like those that can arise from pandemics, natural disasters, armed conflicts overseas, or domestic human and animal food outbreaks. 

This initiative includes: 

  • Streamlining how CVM processes and extracts data from incoming submissions and performs research by reducing redundant or inefficient business processes and leveraging IT solutions that enable CVM to respond at the speed of business; 
  • Modernizing data storage and applying existing data standards to improve the types and quality of information received; 
  • Leveraging best-of-class IT solutions that enable CVM to modernize data reporting capabilities to address ongoing and new public health challenges; and 
  • Remediating any cybersecurity vulnerabilities identified in CVM applications using software and hardware that could result in a release of proprietary data.
 
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