Patient-Focused Drug Development is an initiative that involves obtaining a better understanding of patients’ perspectives on the severity of their disease and the available therapies for their condition. Patient-Focused Drug Development is being conducted to fulfill FDA performance commitments made as part of the authorization of the Prescription Drug User Fee Act under Title I of the Food and Drug Safety and Innovation Act (FDASIA) (Pub. L. 112–144).
The purpose of this webinar is to provide patient stakeholders with a background on the meetings under the Patient-Focused Drug Development initiative. This webinar is split into four modules, each focusing on a separate topic.
Module 1: FDA Background
Module 1 is focused on providing general background on FDA’s history, mission, regulatory authority, and practices.
Module 2: Drug/Biologic Development and Review
Module 2 gives a brief overview of the drug development process, and explains FDA’s role as regulatory authority.
Module 3: OHCA and the Patient Representative Program
Module 3 discusses patient input in the drug development and review process, and explains the role of FDA’s Office of Health and Constituent Affairs (OHCA), formerly known as the Office of Special Health Issues.
Module 4: Introduction to Patient-Focused Drug Development
Module 4 is the final module, and it serves as an introduction to the Patient-Focused Drug Development initiative.