FDA’s Budget: Data Modernization and Enhanced Technologies

“The U.S. Food and Drug Administration’s mission to protect and promote the public health impacts the life of every American, every day. Our work encompasses an ever-widening array of foods, additives, cosmetics, medicines, and medical devices as the FDA regulates approximately 20 cents of every dollar spent annually by American consumers. The industries we regulate are constantly innovating, attracting skilled professionals, and upgrading their technological capabilities. The FDA must keep pace. FDA’s FY 2022 budget requests an increase of $185 million to embark on an effort to upgrade and modernize our physical and technological infrastructure, strengthen our talented workforce, and improve our scientific capability and regulatory structure.”

“Scientific breakthroughs have enabled the development of new, more personalized therapeutic treatments, advanced manufacturing, and modern data solutions such as blockchain, genomic information, and real-time analytics. As a byproduct of these exciting advancements, the amount and variety of data that the FDA generates, needs, and uses is rapidly increasing. But we are often hampered by antiquated methods, including inspecting large volumes of PDFs, often “by hand,” in order to identify critical safety signals, such as human and animal drug and device safety concerns or emerging foodborne outbreaks.”

“The FY 2022 Budget includes $82.9 million — an increase of $75.9 million above the FY 2021 enacted level — for an agency-wide data modernization and enhanced technologies initiative that supports both food safety and medical product safety programs. The initiative includes two components: enterprise technology and data across the foods and medical product programs, and four complementary program-specific investments. These investments will modernize our data infrastructure by using current technology innovations that allow us to more efficiently gather data; identify, analyze, and respond to potential problems more quickly; and further improve review times for medical products…” Read the full article here.

Source: FDA’s Budget: Data Modernization and Enhanced Technologies – By Janet Woodcock, July 6, 2021. FDA.

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