- 2018 / 2019
FDA releases five PFDD draft guidances
Guidance 1 – methods and approaches to patient input throughout the drug development process
Guidance 2 – methods for collecting comprehensive and representative patient and caregiver input on burden of disease and current therapy
Guidance 3 – approaches to identifying important
impacts to patients
Guidance 4 – defines standards for selection, design, and development of clinical outcome assessments
Guidance 5 – informs the use of real-world evidence as part of a regulatory submission to FDA