FDA Policy/General

Patient Experience Data Stakeholder Comments

Federal Register notice: FDA is making available a summary of the comments received for the “Methodological Challenges Related to Patient Experience Data; Request for Information and Comments” notice published 5/2. on May 2, 2023. The input received is intended to help FDA plan two public workshops focused on methodological challenges and will help it identify priorities for future work.

According to the summary, stakeholders requested greater clarity in how FDA uses patient experience data in its regulatory decisions. “Commenters noted that sponsors may be less likely to invest in patient experience data if they do not understand how FDA will use the information, particularly when limited resources are available,” it says. Additionally, stakeholders recommended expanding the patient experience data tables that are included as part of FDA’s review documentation to report whether patient experience data were considered in decision-making and why or why not.

To view the notice, click here.

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome