Collecting data across multiple health care systems, regions, and languages is an important step toward improving health outcomes. Related: 6 ways to bolster FDA’s guidance for diversifying ...

2005: FDA’s Guidance on Data Collection of Race and Ethnicity Data in Clinical Trials requires sponsors to present a summary of safety and effectiveness data by demographic sub-groups for age ...

Alex Ratner, CEO of Snorkel AI, remembers a time when data labeling —the grueling task of adding context to swathes of raw ...

Biopharmas looking to submit a drug ... the data they include—good and bad—and they should get in touch with the agency as early as possible. That’s the headline from new draft guidance ...

Yet if formalized, the guidance could facilitate the ability to use RWE to update a drug’s label with new effectiveness or safety data, say, in a subpopulation or patient group whose numbers perhaps ...