Patient-Focused Drug Development: Collecting Comprehensive and Representative Input | FDA

Patient-Focused Drug Development: Collecting Comprehensive and Representative Input | FDA

The U.S. Food and Drug Administration is announcing the availability of a guidance for industry, FDA staff, and other stakeholders entitled "Patient-Focused Drug Development: Collecting Comprehensive and Representative Input." This guidance finalizes the draft guidance of the same name issued on June 13, 2018. This guidance (Guidance 1) is the first of a series of four guidance documents that FDA committed to develop to address, in a stepwise manner, how stakeholders (patients, researchers, medical product developers, and others) can collect and submit information on the patient experience for medical product development and regulatory decision making.  This series of guidance documents is intended to facilitate the advancement and use of systematic approaches to collect and use robust and meaningful patient and caregiver input that can more consistently inform medical product development and regulatory decision making.