How to use registry data to support FDA decision making: Agency explains in new guidance
by Zachary Brennan
Senior Editor
EndPoints
Drugmakers looking to design a new registry or use an existing one to support a regulatory decision on a drug’s effectiveness or safety will need to consult with a new draft guidance released Monday by the FDA.
The agency’s reliance on registry data for regulatory decisions dates back more than two decades, at least, as in 1998 Bayer won approval for its anticoagulant Refludan (withdrawn from the market in 2013 for commercial reasons) based in part on a historical control group pulled from a registry.
The new 14-page draft guidance makes clear that although registries may have advantages over other real-world data sources, registries are far from perfect sources of information. FDA had to craft this guidance under the 21st Century Cures Act as part of a broader
