Docket Number:
FDA-2018-D-1893
Issued by:
Guidance Issuing Office
Center for Drug Evaluation and Research

[Final posted 6/16/2020]

This guidance (Guidance 1) is the first of a series of four methodological patient-focused drug development (PFDD) guidance documents3 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 data4 and other relevant information from patients and caregivers for medical product5 development and regulatory decision making.

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All written comments should be identified with this document's docket number: FDA-2018-D-1893.