To keep up with an increasingly data-rich health ecosystem, FDA is implementing a multi-year strategic plan to modernize its technology infrastructure—boosting cloud capabilities and building sophisticated data analytics for using real-world evidence to support regulatory decisions.
Last December, Flatiron Health convened a “hackathon,” an event where programmers, developers, and scientists pitch novel ideas and aggressively crunch data in a competitive sprint.
FDA has issued a draft guidance that describes the types of real world data and real world evidence that the agency would accept as part of regulatory submissions for drugs and biologics.
We posed the same 10 questions to FDA, Pfizer and Flatiron Health. Here is what came back:
Real world data played a role in FDA's recent decision to expand the indications for Pfizer's drug Ibrance (palbociclib) to include men.
FDA is enhancing its ability to handle real-world evidence by training reviewers in data science via a curriculum on machine learning and artificial intelligence, said FDA Commissioner Scott Gottlieb.
FDA has created a framework for evaluating the use of real-world evidence to support additional indications for already approved drugs as well as to satisfy drug post-marketing study requirements.
