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BIO Comments on FDA Draft Guidance on Developing and Submitting Proposed Draft Guidance Relating to Patient Experience Data

March 21, 2019

BIO submitted comments on the Food and Drug Administration’s (FDA) Draft Guidance, Developing and Submitting Proposed Draft Guidance Relating to Patient Experience Data.

In the comments, BIO thanks FDA for promoting partnership between patients, industry, and the FDA by providing patient groups and other stakeholders with a pathway to submit proposed draft guidance and other resources related to patient experience data. BIO encourages FDA to continue to facilitate the open exchange on patient experience data with all stakeholders, which will lead to more meaningful outcomes.

BIO believes strong trilateral communication between the FDA, patients/patient organizations, and Sponsors will help better incorporate patient experience data throughout the product lifecycle, including drug development and review. BIO provides recommendations on how the FDA can better support this trilateral communication, such as the process by which FDA will communicate and provide feedback to stakeholders who submit draft guidance or other data, when dockets are open for stakeholder comments, and how FDA staff will engage with stakeholders around patient experience data.

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BIO Comments Developing And Submitting Proposed Draft Guidance Relating To Patient Experience Data FDA-2018-D-4455
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