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  1. Advancing Regulatory Science

Executive Summary: Strategic Plan for Regulatory Science

The Food and Drug Administration (FDA) protects and promotes the health and safety of all Americans through enhancing the availability of safe medical products and foods and promoting innovation that addresses unmet medical and public health needs. FDA also protects and promotes the health and safety of animals through assuring the availability of safe animal drug products and food. FDA is a science-based regulatory agency and a critical component to the success of the nation’s public health, health care systems, and economy. FDA was created in 1906 as one of our nation’s principal consumer product protection agencies, and is now responsible for assuring the safety of biologics, such as blood products and vaccines, drugs, medical devices, foods, cosmetics, and many other consumer goods. Since 2009, it has also been responsible for regulating the manufacture, marketing, and distribution of tobacco products. In the U.S., FDA-regulated products account for about 25 cents of every dollar spent by American consumers each year — products that touch the lives of every American every day. FDA is responsible for advancing the public health by helping to speed innovations that make foods safer and make medicines and devices safer and more effective. At the same time, FDA helps consumers and health care providers get the accurate and science-based information they need to make the best possible decisions about their use of medical products and foods for human and non-human animal use. FDA must make decisions based on the best available scientific data and using the best tools and methods available in order to ensure products meet the highest quality standards for consumers, while at the same time fostering and advancing innovation in the products it regulates.

The core responsibility of FDA is to protect consumers by applying the best possible science to its regulatory activities — from pre-market review of efficacy and safety to post-market product surveillance to review of product quality. In the last few years, rapid advances in innovative science have provided new technologies to discover, manufacture and assess novel medical products, and to improve food safety and quality; FDA must both keep pace with and utilize these new scientific advances in order to accomplish its mission to protect and promote the health of our nation.

FDA’s Strategic Plan for Regulatory Science

To meet this need, FDA has developed a 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 plan identifies eight priority areas of regulatory science where new or enhanced engagement is essential to the continued success of FDA’s public health and regulatory mission. The priority areas are:

  1. Modernize Toxicology to Enhance Product Safety
  2. Stimulate Innovation in Clinical Evaluations and Personalized Medicine to Improve Product Development and Patient Outcomes
  3. Support New Approaches to Improve Product Manufacturing and Quality
  4. Ensure FDA Readiness to Evaluate Innovative Emerging Technologies
  5. Harness Diverse Data through Information Sciences to Improve Health Outcomes
  6. Implement a New Prevention-Focused Food Safety System to Protect Public Health
  7. Facilitate Development of Medical Countermeasures to Protect Against Threats to U.S. and Global Health and Security
  8. Strengthen Social and Behavioral Science to Help Consumers and Professionals Make Informed Decisions about Regulated Products

FDA will apply available resources to implement the Strategic Plan for Regulatory Science through management of scientific programs within FDA and engagement of collaborators and partners in industry, academia and government. FDA’s Strategic Plan for Regulatory Science is designed to allow the Agency both to meet today’s public and animal health needs and to be fully prepared for the challenges and opportunities of tomorrow to help harness revolutions in science that can be translated into products that help make and keep our nation both safe and healthy.

Table of Contents: Strategic Plan for Regulatory Science

Next Section: Introduction

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