Introduction: Strategic Plan for Regulatory Science
FDA is responsible for assuring the safety of foods, drugs, medical devices, biologics—such as vaccines, blood products, cell and gene therapy products, and tissues—cosmetics, and many other consumer goods, as well as foods and drugs for animals. Since 2009, it has also been responsible for regulating the manufacture, marketing, and distribution of tobacco products. FDA is also responsible for advancing the public health by helping to speed innovations that provide our nation with safe and effective medicines and devices and keep our food supply safe, while helping Americans get the accurate, science-based information they need to use medical products and consume foods to improve and maintain their health.
The complexity of FDA‘s regulatory and public health portfolio is growing rapidly, in large part due to scientific challenges inherent in evaluating a new generation of products based on quickly evolving science and technology. Layered on this are the realities of an expanding global economy that requires FDA to evaluate and manage risks associated with a vast array and volume of regulatory data, products, and ingredients produced in a multitude of global locations. New drugs, biologics and medical devices are increasingly complex in their development, manufacture, and evaluation. Sophisticated global markets move foods from foreign farms to supermarkets with increasing speed. Finished products may contain a complicated array of ingredients and components, all sourced from shifting global commodities markets and often of uncertain provenance. The addition of tobacco products to FDA's regulatory responsibilities poses new regulatory challenges in need of new scientific solutions to better protect the public from harm. In addition, improved information technology capacity provides opportunities to harness the substantial data resources both within and external to FDA for regulatory decision-making.
The challenges of modern product development and globalization underscore the critical importance of modernizing and advancing regulatory science to match advances in basic and applied science and technology. Clearly for scientific advances to realize their full potential for improving public health, FDA must be able to issue clear guidance, play a major role in the improvement of modern product and process development tools, and make sound regulatory decisions about risks and benefits of products that increasingly involve new technologies.
To help meet these challenges, FDA has developed this Strategic Plan for Regulatory Science, the science of developing new tools, standards, and approaches to assess the safety, efficacy, quality, and performance of FDA-regulated products. This work builds upon the white paper Advancing Regulatory Science for Public Health 1 and the FDA Strategic Priorities. 2 In this work, FDA identifies priority areas where new or enhanced investments in regulatory science research capacity will be essential to continued mission success and to public health and safety.
FDA will accomplish this plan by applying its knowledge base, laboratories, scientific computing capabilities, and expertise, while leveraging resources and collaborating with domestic and international partners in government and academia. Where appropriate, FDA will also engage stakeholders from the private sector in this effort. FDA will use this plan to ensure that its regulatory science programs focus on the identified priorities, in combination with Center specific approaches, but will also revisit these priorities regularly, and seek public input to address evolving challenges, opportunities and changes in the science and innovation landscape.
1. Advancing Regulatory Science for Public Health accessible at: https://www.fda.gov/media/79184/download
2. FDA Strategic Priorities