Content by Thinh Nguyen, Rachel E. Sherman
FDA Introduces the Pre-RFD ProcessMaking continuous improvements in the combination products program
Thu, 08/25/2016 - 16:43
One question that product sponsors often ask the U.S. Food and Drug Administration (FDA) is whether their medical product will be regulated as a drug, a device, a biologic, or as a combination product—and in the case of the latter, which FDA… What We Mean When We Talk About EvGen, Part 2Building out a national system for evidence generation
Tue, 05/24/2016 - 14:30
In an earlier article, we discussed a pair of concepts—interoperability and connectivity—that are essential prerequisites for creating a successful national system for evidence generation (or “EvGen”). Here, we take a look at how we would apply… What We Mean When We Talk About EvGen, Part 1Laying the foundation for a national system for clinical evidence generation
Thu, 04/28/2016 - 12:23
Across the clinical research enterprise, there is a growing awareness of serious shortfalls in the current model for generating the scientific evidence that supports medical product evaluation and clinical care decisions. As a result the FDA seeks… What We Mean When We Talk About ‘Data’FDA defines some terms
Thu, 01/07/2016 - 16:04
Medical care and biomedical research are in the midst of a data revolution. Put together, networked systems, electronic health records, electronic insurance claims databases, social media, patient registries, and personal devices comprise an…
