Aetion Urges FDA To Establish Cloud-Based RWE Platform
Aetion has issued a call for the FDA to implement a cloud-based real-world evidence (RWE) platform with robust data governance so that users can do data queries, archiving, access, and aggregation. Such a system, the company says, could help avoid unnecessary data duplication and support concurrent reviews by global regulators. The FDA was going to discuss its September 2019 Technology Modernization Action Plan, an overarching plan that could include the use of RWE, at a meeting on March 27, but the meeting was rescheduled for June...