January 7, 2020

Media Inquiries

  Stephanie Caccomo
  240-762-8873

The following quote is attributed to FDA Commissioner Stephen M. Hahn, M.D.:

 

“Data are the foundation of our most important work as a science-based regulatory agency—from reviewing medical products to identifying the source of a food-borne illness outbreak.”

“Because data are so essential to what we do, we are committed to ensuring that our mechanisms for collecting, reviewing and analyzing data are equally as sophisticated as the scientific advances that we are reviewing.”

The following quote is attributed to FDA Principal Deputy Commissioner Amy Abernethy, M.D., Ph.D.:

“Critical steps in transforming our computing and technology infrastructure are reflected in the FDA’s Technology Modernization Action Plan. This plan is an important step in closing the gap between scientific advances and the computing solutions needed to translate those advances into new therapies for patients.”

“The next step is to combine our computing capability with state-of-the-art approaches in data management, analysis and decision-making. We will work with internal and external experts on how to best approach important topics like data stewardship, strategy, standards and more. Our March 27 public meeting we’re announcing today provides a critical opportunity for public input and engagement on this important topic. Data strategy relates directly to the products we regulate, the efficiency of our agency and our public health mission.”

• Today, the U.S. Food and Drug Administration announced it is holding a public meeting on March 27, 2020 at the FDA’s White Oak campus on “Modernizing FDA’s Data Strategy.”
• The purpose of the public meeting and the request for comments is to discuss possible agency-level approaches to modernizing the FDA’s data strategy, including approaches to data quality, data stewardship, data exchange and data analytics.
• This meeting is part of the FDA’s efforts to modernize technology used at the agency, as detailed in the Technology Modernization Action Plan (TMAP), released in September 2019. The TMAP describes steps the FDA is taking to modernize the use of technology, including computer hardware, software, cloud-based solutions and data exchange. The FDA’s data strategy meeting announced today is the next step in these efforts.
• The FDA will continue to provide updates on the TMAP, including opportunities for future engagement with the agency, such as innovation challenges designed to encourage collaboration with the FDA.

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.