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U.S. Department of Health and Human Services

Science & Research

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About Science & Research at FDA

 

Scientist looking through a microscope


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FDA's mission is to protect and advance public health by helping to speed innovations that provide our nation with safe and effective medical products and that keep our food safe. The Agency achieves this by applying the latest technology and science-based standards to the regulatory challenges presented by drugs, biologics (vaccines, blood products, cell and gene therapy products, and tissues), medical devices, and food additives.

Since its enactment in 1938, FDA has seen an enormous increase in the magnitude and complexity of its regulatory responsibilities.  New areas of science, evolving technologies, and globalization have profoundly altered the Agency's regulatory landscape.  
 
Today FDA's regulatory activities range from review and assessment of human and animal clinical data and inspection of facilities to developing technical and scientific standards for product development, manufacturing, food safety standards, and surveillance of adverse events, to name just a few.  
 
Such activities require the support of a scientific staff from disciplines as diverse as molecular biology, nuclear physics, and engineering. FDA's scientific knowledge, skills, and research base is crucial to the Agency's ability to conduct modern regulatory research. This research is key to FDA's capacity to monitor and evaluate the safety and efficacy of new and licensed products and to transform or create new regulatory pathways so that new treatments get to people who need them when they need them.
 
FDA is implementing its Strategic Plan for Advancing Regulatory Science (the science of developing novel tools, standards, and approaches to assess the safety, efficacy, quality, and performance of its regulated products) to meet the new challenges of 21st-century product development and globalization.
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Research at FDA

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