Issue Date: June 13, 2018
Issued by: Center for Drug Evaluation and Research
Topic(s): Administrative / Procedural
Status: Final
Patient-Focused Drug Development: Collecting Comprehensive and Representative Input
This guidance (Guidance 1) is the first of a series of four methodological patient-focused drug development (PFDD) guidance documents 3 that FDA is developing to address, in a stepwise manner, how stakeholders (patients, researchers, medical product developers and others) can collect and submit patient experience data 4 and other relevant information from patients and caregivers for medical product 5 development and regulatory decision making.
Download the Guidance Document
