Supporting detail
Technology is the enabler, not the whole story
The transcript points to cloud computing, electronic health records, and AI tools, but always inside a broader process redesign story.
Cloud and EHR access
Makary said this is possible now because of cloud computing and the scale of electronic health records, with patient consent.
Connected idea: this is being enabled by infrastructure that did not exist earlier.
A reviewer-facing dashboard
FDA said reviewers were shown a dashboard of clinical endpoints and safety signals and immediately saw future potential for more data points.
Connected idea: the model is also changing how reviewers interact with a live trial.
Other uses of technology
The Commissioner also mentioned an internal AI tool that shortens a two-month filing period to about two minutes.
Connected idea: FDA is pairing the real-time trial announcement with broader modernization themes.
Common sense modernization
Makary called the effort FDA common-sense modernization, showing that the transcript frames technology as practical process improvement.
Connected idea: better tools are meant to remove delay, not add hype.