Developing and Submitting Proposed Draft Guidance Relating to Patient Experience Data

Issue Date: December 21, 2018
Issued by: Center for Drug Evaluation and Research,Office of Regulatory Policy
Topic(s): Administrative / Procedural, Generic Drugs
Status: Draft

Developing and Submitting Proposed Draft Guidance Relating to Patient Experience Data

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled “Developing and Submitting Proposed Draft Guidance Relating to Patient Experience Data.” This draft guidance is being developed under the 21st Century Cures Act (Cures Act), which directs FDA to issue guidance on how a person seeking to develop and submit a proposed draft guidance relating to patient experience data for consideration by FDA may submit such proposed draft guidance to the Agency.

Download the Guidance Document