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  6. Public Health Preparedness and Response
  1. Focus Areas of Regulatory Science Report

Public Health Preparedness and Response

 

A collage of photos showing a vaccine vial, a microscope in front of fresh vegetables, a scientist holding test tubes in a laboratory, a digital illustration of antibodies, and a biotechnologist checking for bacteria in a food sample landscape.

Introduction

FDA prepares to respond to a wide variety of natural and human-caused threats and public health emergencies (e.g., COVID-19) that involve, affect, or require the use of FDA-regulated products to help keep the public safe. FDA carries out many activities to protect and advance public health and to prevent and respond to public health emergencies.

In response to a public health emergency, FDA’s research amplifies the many regulatory activities that take place. This includes development of standards, panels, and reagents to help speed the development and availability of potential vaccines, diagnostics and therapeutics; maintaining and securing drug supply chains; expediting approval of generics to help alleviate drug shortages; providing guidance to food and medical device manufacturers; advising developers on clinical trial issues; and keeping the public informed with fact-based health information. FDA oversees the repurposing of existing drugs and the development and approval of new drugs and vaccines by working with potential manufacturers and sponsors to rapidly move products into clinical trials, while helping to ensure the trials are properly and safely designed.

FDA actively communicates in real-time with hospitals across the United States and external stakeholders about their drug supply needs. FDA builds capacity through partnerships, including the Laboratory Flexible Funding Model to increase chemical, radiological and microbiological resources for domestic partners to respond to public health events.

 

 

 

CROSS-CUTTING TOPICS

Minority Health and Health Equity Women’s Health Maternal Health Pediatric Health
Oncology Rare Diseases One Health Initiative  

 

EXPLORE THE FOCUS AREAS OF REGULATORY SCIENCE

Advanced Manufacturing Antimicrobial Resistance Artificial Intelligence Biomarkers
Complex Innovative Trial Design Digital Health Technologies Empowering Patients and Consumers to Make Better-Informed Decisions Food Safety
Increasing Access to Complex Generic Drug Products Individualized Therapeutics and Precision Medicine Medical Countermeasures and Preparedness for Emerging Infectious Diseases Microbiome Research
Model-Informed Product Development Novel Foods and Food Ingredients Novel Technologies to Improve Predictivity of Non-clinical Studies and Replace, Reduce, and Refine Reliance on Animal Testing Patient and Consumer Preferences and Perspectives
Patient-Reported Outcomes and other Clinical Outcome Assessments Product Safety Surveillance Quality of Compounded Drugs Regenerative Medicine
  Substance Use Disorders Technologies to Reduce Pathogen Contamination Use of Real-World Evidence to Support Biologic, Device, and Drug Development and Regulatory Decision-Making

 

Research Capabilities, Tools, and Resources

Research Management and Collaborations Technology Transfer and Public-Private Partnerships Physical Standards and Reference Materials Intramural Grant Programs Extramural Funding Mechanisms

Scientific Education, Training, and Communication

Fellowship and Training Opportunities Professional Development and Continuing Education Communication and External Meetings

Infrastructure

Facilities and Shared Resources Safety and Compliance

 

ADDITIONAL ORGANIZATIONAL INFORMATION

Office of the Chief Scientist

Office of Regulatory Science and Innovation

 Contact Us: FARS@fda.hhs.gov

 

 
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