This is the third in a series of reports from the Planning Board to support the U.S. Food and Drug Administration’s (FDA) work to establish the National Evaluation System for health Technology (NEST). NEST is envisioned as a cooperative network of partners working to use data, advanced...

In this white paper, a working group of experts address key challenges in biomarker development and validation, including inconsistent terminology; confusion surrounding the various regulatory pathways for biomarker acceptance; the need for data standards and improved collaboration in data...

As officials reel from the news that a “superbug” strain of E-coli resistant to colistin, the antibiotic of last resort, has arrived in the United States, leaders in Europe have issued guidance on policy measures aimed at avoiding this worst-case scenario. Dangerous bacteria are becoming...