FDA Finalizes First of Four PFDD Industry Guidances By Marina Ness, MA On June 16th, the FDA released the final version of “Patient-Focused Drug Development: Collecting Comprehensive and Representative Input.” This document, referred to as Guidance 1, advises industry on methodologies they can use to collect patient input that will be considered [...]
Diversity in Clinical Trials: Being Left Out By Marina Shayevich Why do African Americans develop breast cancers with significantly higher basal gene expression? 1 Why do Hispanics develop type II diabetes at an earlier age than other groups? 2 Understanding the functional reasons for disease processes is necessary to develop targeted treatments. Yet [...]
Social Listening to Understand the Unmet Needs of Patients By Marina Shayevich and Sara Ray Across healthcare, patients lament the imperfection of pharmaceutical treatment. Although grateful to have life saving and life improving medications, patients are often met with frustration at the limitations of their medications. Nowhere is that more evident than [...]
