By Patrizia Cavazzoni MD & Peter Marks MD PhD – An estimated 10,000+ rare diseases affect more than 30 million people – approximately one out of every 10 people – in the U.S., and about half of these people are children. Many rare conditions are life threatening, and most do not have approved treatments.
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By Patrizia Cavazzoni MD – AI and ML are no longer futuristic concepts; they are now part of how we live and work. The FDA uses the term AI to describe a branch of computer science, statistics, and engineering that uses algorithms or models to perform tasks and exhibit behaviors.
By Stephen M. Hahn MD, Patrizia Cavazzoni MD, & Peter Marks MD, PhD – When the U.S. Food and Drug Administration learned of the novel coronavirus (COVID-19) and its potentially devastating effects, we acted swiftly to set the regulatory stage for drug and biologics manufacturers to develop products to treat this serious disease.