Docket Number:
FDA-2018-D-4455
Issued by:
Guidance Issuing Office
Center for Drug Evaluation and Research, Office of Regulatory Policy
Center for Biologics Evaluation and Research

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled “Developing and Submitting Proposed Draft Guidance Relating to Patient Experience Data.” This draft guidance is being developed under the 21st Century Cures Act (Cures Act), which directs FDA to issue guidance on how a person seeking to develop and submit a proposed draft guidance relating to patient experience data for consideration by FDA may submit such proposed draft guidance to the Agency.

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All written comments should be identified with this document's docket number: FDA-2018-D-4455.