By Patrizia Cavazzoni MD & Peter Marks MD PhD – Through the Hub, we plan to foster a community at the FDA for open dialogue and knowledge sharing to identify new approaches to drug and biologic development and overcome hurdles that have traditionally impeded progress for rare disease treatments.
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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.
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.