By Robert Califf – What we now call real-world data (RWD) have been used for years in medical product development to inform study design and endpoint selection, identify potential participants and trial sites, and assess safety in the post-marketing setting.
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By Vid Desai & Jessica N. Berrellez – The U.S. Food and Drug Administration has released its comprehensive FDA Information Technology Strategy for Fiscal Years 2024 to 2027 (IT Strategy), marking a defining roadmap for the agency’s technological advancement and the alignment with its broader public health mission.
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.
The thought leaders in our community are good about sharing their thoughts on the issues of today. Here are the top read and shared guest posts of December that we think deserve sharing again.
By Vid Desai & Jessica N. Berrellez – Digital transformation is a continuous journey that touches every part of an organization. The FDA established the Office of Digital Transformation in September 2021.
By Vid Desai & Craig Taylor – The U.S. Food and Drug Administration is critical to protecting and promoting public health. The products the FDA regulates are in every supermarket, pharmacy, and home across the U.S. Cybersecurity touches every facet of the FDA’s broad, complex responsibility.
By Hilary Marston MD MPH & Ann Meeker-O’Connell MS – Clinical trials play a crucial role in advancing science and supporting the development of new medical products to address unmet patient needs. Reliable data from well-designed trials about a medical product’s safety and effectiveness are critical.
By Jeff Shuren MD JD & William Maisel MD – Since the beginning of the COVID-19 pandemic, the demand for medical devices has far exceeded anything we have seen in previous public health emergencies. The FDA’s Center for Devices and Radiological Health has worked to address these unprecedented demands…
By Robert M. Califf MD, MACC & Vid Desai – Technology and data have disrupted our world in ways unimaginable only 20 years ago – including how the world thinks about health. The COVID-19 pandemic accelerated these changes and underscored the importance of…