Typically, we assume that data exist whether or not we observe them. But HOW we observe situations to collect data inextricably changes the manner in which they are collected and where the analyses lead. This, ultimately, has a direct influence on the diseases and disorders which get focus and attention and which do not. As well, this principle influences which therapies gain a favorable evaluation by regulatory authorities, versus those that do not. This is all very important context to understand the FDA’s new Data Modernization Action Plan (DMAP), which is a framework for how it will handle, analyze, and respond to data which it receives.

Major themes:

• What surprises will COVID-19 bring to us next?
• How are we preparing?
• FDA Modernization: The future is now (DMAP, new data, ‘bigger data,’ faster data)
• You can’t commercialize that which isn’t approved!