The FDA is developing a series of four methodological patient-focused drug development (PFDD) guidance documents to address, in a stepwise manner, how stakeholders can collect and submit patient experience data and other relevant information from patients and caregivers for medical product development and regulatory decision making.

In today's episode, we discuss the process with the FDA publishing a timeline of planned public workshops, draft guidance documents and final guidance documents for 4 documents, originally planned to finish in end 2021 and its objective to explore the factors that need to be considered when developing COA-based endpoints.

Podden och tillhörande omslagsbild på den här sidan tillhör Alexander Schacht and Benjamin Piske, biometricians, statisticians and leaders in the pharma industry. Innehållet i podden är skapat av Alexander Schacht and Benjamin Piske, biometricians, statisticians and leaders in the pharma industry och inte av, eller tillsammans med, Poddtoppen.