- 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