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From Your Fitbit to Pharmaceuticals, FDA Eyes Real-World Data (1)

May 8, 2019, 1:47 PM; Updated: May 8, 2019, 4:15 PM

Drug companies culling data from your Fitbit or other electronic health records for their products have new guidelines on how FDA wants to see that information present in pharmaceuticals applications.

The Food and Drug Administration issued a draft guidance May 8 on how to submit documents using real-world data and evidence to the agency for drugs and biologics. The draft document represents the first how-to guide on an issue that’s been an agency priority for several years: making the expensive, costly drug development process more efficient by harnessing existing data sources. It’s a major shift from relying entirely on clinical ...

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