FDA Finalizes First of Four PFDD Industry Guidances

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 scientifically valid for the drug and device regulatory approval process -- including guidance on using input from social media. It is the first finalized version of the set of four planned guidances for making the patient perspective part of FDA regulatory approval. All of the [...]

How has the COVID-19 Pandemic Impacted Chronically Ill Patients? Patient Reported Outcomes

How has the COVID-19 Pandemic Impacted Chronically Ill Patients? Patient Reported Outcomes By Kathleen Hoffman, PhD, MSPH Research in health and medicine has largely used quantitative methods. Using mixed methods, combining qualitative research with quantitative, is still relatively new. As the COVID-19 pandemic moved the world home and online, our team of qualitative researchers1 (while respecting member privacy) observed and documented themes within the online communication of chronically ill patients on Inspire. Inspire fielded a quantitative survey to document the impact. Telehealth Appointments In May the team observed and documented comments about telehealth appointments. They found patients [...]