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U.S. Department of Health and Human Services

Science & Research

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The Promise of Regulatory Science

Table of Contents: Advancing Regulatory Science for Public Health

What is regulatory science?

Regulatory science is the science of developing new tools, standards and approaches to assess the safety, efficacy, quality and performance of FDA-regulated products.

What is the potential of regulatory science?

The field of regulatory science — both the knowledge generated in developing new tools and the tools themselves — has the potential to inform a broad range of health-related advances, involving numerous diseases and conditions. For example, a project to explore how to characterize and predict undesired immune responses that can alter or block the effects of recombinant proteins and monoclonal antibodies can demonstrate relevance to the treatment of cancer, rheumatoid arthritis and other diseases. The knowledge generated from such studies may well be applicable across entire classes of food and medical products and could help better ensure that such medicines are both safe and effective.

Regulatory science does not take place only in laboratories. It involves scientific tools and information-gathering and analytical systems to study data, people, health systems and communities. To be most effective, advances in regulatory science must be fully integrated into the entire product development process. Outreach and collaborative efforts are integral to predicting the failure or success of new discoveries and technologies early in development, reducing product development costs. Advances in regulatory science will help make the evaluation and approval process more efficient, helping to deliver safe new products to patients faster and strengthening the ability to monitor product use and improve performance, thus enhancing patient outcomes.

What are the priorities for regulatory science?

With a focused agenda and targeted investment of human and financial resources, FDA will continue its work with its partners to transform the culture and science of product research, development, and evaluation — and infuse the process with new creativity.

The pages that follow will illustrate the current activities and future opportunities for regulatory science to tackle some of the most important and pressing public health challenges facing Americans today:

  1. Accelerating Delivery of New Medical Treatments to Patients
  2. Improving Pediatric and Child Health
  3. Protecting Against Emerging Infectious Diseases and Terrorism
  4. Enhancing Safety and Health Through Informatics
  5. Protecting the Food Supply
  6. Modernizing Safety Testing
  7. Meeting the Challenges for Regulating Tobacco 

Next Section: Accelerating the Delivery of New Medical Treatments to Patients