Norton Rose Fulbright: Rise Of Predictive Coding For Pharmaceutical Companies

By Jessica Sykora | Pharmaceutical and medical device companies in the midst of costly e-discovery battles and high-dollar litigation have more than likely heard the buzzwords "predictive coding" and "computer-assisted review" at some point during strategy sessions over how to...

Norton Rose Fulbright: FDA’s Expanded Oversight Of ‘High-risk’ Diagnostic Devices

By Cori Annapolen Goldberg and Lidia Niecko-Najjum In efforts to ensure that in vitro diagnostic devices 1 provide accurate, consistent and reliable results, the US Food and Drug Administration ("FDA" or "the Agency") 1) issued a final guidance on the development, review and approval...