“The Food and Drug Administration is leveraging patient experience data for regulatory decision-making, with change management of its workforce key to the next steps in this digital transformation.”
“The effort stems from FDA’s June report, titled ‘Assessment of the Use of Patient Experience Data in Regulatory Decision-Making,’ which outlines methods used to identify, collect and analyze patient data in decision-making.”
“’FDA will use this report to support its efforts to enhance the use of patient experience data in regulatory decision-making, which can help ensure that as a medical product is developed, it is developed in a way that takes into account the needs and priorities of the patients who will use the product,’ Mary Ann Slack, director of the Office of Strategic Programs with FDA’s Center for Drug Evaluation and Research, told GovernmentCIO Media & Research.”
“Over the past year, FDA has accelerated data efforts to create modern data solutions like blockchain, genomic information and real-time analytics. The agency has experienced dramatic increases in data collection, especially following the onset of COVID-19.”
“’Technological advances have and will continue to revolutionize human and animal health,’ Janet Woodcock, FDA’s acting commissioner, said during a budget hearing in June. ‘As a byproduct of these exciting advances, the amount and variety of data that FDA generates, needs and uses is rapidly increasing, but we’re often hampered by antiquated methods.'”
“FDA’s Center for Drug Evaluation and Research was, and continues to be, a central hub for FDA’s COVID-19 response and for patient data collection to ensure quick delivery of therapeutics for public health…” Read the full article here.
Source: How FDA is Approaching Change Management in New Data Efforts – By Sarah Sybert, August 6, 2021. GovernmentCIO.
