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The Division of Drug Information (DDI) - serving the public by providing information on human drug products and drug product regulation by FDA


Today the U.S. Food and Drug Administration (FDA) issued a draft guidance on Developing and Submitting Proposed Draft Guidance Relating to Patient Experience Data. This draft guidance provides information on how a person can submit a proposed draft guidance relating to patient experience data for consideration by FDA. In addition, FDA recognizes that stakeholders may have other information on patient experience data that they would like to share with the agency outside of the guidance process. This draft guidance also provides information on other ways stakeholders can advance drug development by sharing patient experience data. 

Specifically, the draft guidance addresses questions related to the development and submission of proposed draft guidance relating to patient experience data, such as:
  • What factors should stakeholders consider when planning and determining whether to develop a proposed draft guidance relating to patient experience data to submit to FDA?
  • How can stakeholders communicate with FDA that they plan to develop a proposed draft guidance relating to patient experience data?
  • What are some general considerations regarding format of the proposed draft guidance?
  • How should stakeholders submit proposed draft guidance to FDA?
  • What will happen after stakeholders submit the proposed draft guidance to FDA?
  • Can a stakeholder submit proposed revisions to an existing FDA guidance?
  • What are other ways for a stakeholder to participate and provide input on FDA policy and guidance development?
Interested parties are encouraged to submit comments on this draft guidance through the associated docket (FDA-2018-D-4455). 

For more information on the Center for Drug Evaluation and Research’s Patient-Focused Drug Development program please visit our website


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