The FDA details their plans to advance regulatory science in 2021

The US Food and Drug Administration (FDA) have released a report on their Focus Areas of Regulatory Science (FARS) for 2021. This document aims to “identify and communicate priority areas where new or enhanced investments in regulatory science research capacity are essential to support FDA’s regulatory and public health mission”.

Three core strategic initiatives first identified at the start of 2020 make up the bulk of the report:

  • Increasing Choice and Competition through Innovation
  • Unleashing the Power of Data
  • Empowering Patients and Consumers

The FARS report also includes a section on Public Health Emergency Preparedness and Response, largely as a result of the COVID-19 pandemic. However, this segment also details other public health related issues including substance use disorders, antimicrobial resistance, food safety and the quality of compounded drugs.

Increasing Choice and Competition through Innovation

The FDA’s Emerging Sciences Working Group forms a core component of this strategic initiative. Using a “horizon-scanning” approach to identify new and emerging scientific trends enables this group to help the FDA adjust its working practices in order to best regulate any products that will emerge from these fields, whilst simultaneously supporting innovation. Consequently, this group is interested in highly advanced and/or emerging fields such as microbiome research, regenerative medicine, and novel foods and food ingredients. In order to support regulatory science in these fields and many others, the FDA supports the advancement of Complex Innovative Clinical Trial Design and Advanced Manufacturing Techniques as methods of addressing the challenges in the development and production of products.

Unleashing the Power of Data

The FDA acknowledges the importance of using reliable data sources combined with improved analytics of datasets when it comes to aiding their work in regulatory science. The report describes various techniques and resources being employed in this field, for instance, the use of machine learning and artificial intelligence in the analysis of large and complex data sets. Through analysing data captured from active surveillance systems such as the FDA Sentinel System (Sentinel) and the Biologics, Effectiveness and Safety (BEST) system, the FDA hopes to harness the power of real-world evidence (RWE). In this way, the FDA is aiming to unleash the power of data to support product development and regulatory-decision making.

Empowering Patients and Consumers

This initiative revolves around understanding patient and consumer preferences, perspectives and outcomes. This will allow the FDA to “develop targeted, relevant and easy-to-understand communications and resources” with the aim of enhancing public education, in turn enabling them to make improved and informed decisions. Additionally, the focus on patient-reported outcomes (PROs) is an area that the FDA hopes will allow improved regulatory-decision making that is of benefit to patients and caregivers.

Access to the full FARS report can be found here.