Although the FDA has gone to great lengths to integrate RWD into the fight against COVID-19, the agency still has a long way to go. The FDA’s Amy Abernethy rated the agency’s current efforts to deal with COVID-19 as a 2 out of 10. “I’m going to give us a 2,” she said. “And it’s a 2 on execution, and an 8 or 9 on vision of where this goes.” “This low score is due to the large amount of effort needed to understand what datasets are available, how they can be used with confidence, the right methods for using them, and the research questions they can address now and potentially in the future,” Abernethy said. Access the full report here.
(Source: Sue Sutter, Pink Sheet, September 2, 2020)