Woodcock: Biomarker Provisions Of Cures Draft Essentially Codify FDA Practices

FDA drug chief Janet Woodcock told lawmakers at a House Energy and Commerce health subcommittee meeting on April 30 that provisions on surrogate endpoints and biomarkers in the second draft of 21st Century Cures legislation essentially codify programs the agency already has in place. She said progress on widening the use of biomarkers in clinical trials is slow because there are still gaps in the science, but FDA has allowed a number of manufacturers to use biomarkers through confidential user...