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  4. Patient-Focused Drug Development: Workshop to Discuss Methodologic and Other Challenges Related to Patient Experience Data - 12/13/2024
  1. News & Events for Human Drugs

Virtual | Virtual

Event Title
Patient-Focused Drug Development: Workshop to Discuss Methodologic and Other Challenges Related to Patient Experience Data
December 13, 2024

Date:
December 13, 2024
Time:
10:00 a.m. - 5:00 p.m. ET

On December 13, 2024, FDA hosted a virtual public workshop to discuss methodological challenges related to patient experience data, including the submission and evaluation of patient experience data in the context of the benefit-risk assessment and product labeling, as well as other areas of greatest interest or concern to public stakeholders. This workshop explored the different types of patient experience data and how FDA utilizes such data for regulatory decision-making, along with considerations for submitting patient experience data to FDA. In addition, this workshop featured presentations and panel discussions with experts on selected methodologies and the challenges and opportunities they present.

Background:

Under the seventh iteration of the Prescription Drug User Fee Act, incorporated as part of the FDA User Fee Reauthorization Act of 2022, FDA committed to facilitate the advancement and use of systematic approaches to collect and utilize robust and meaningful patient and caregiver input that can more consistently inform drug development and, as appropriate, regulatory decision making. This included issuing a Request for Information (RFI) available at https://www.federalregister.gov/documents/2023/05/02/2023-09265/methodological-challenges-related-to-patient-experience-data-request-for-information-and-comments to elicit public input on methodologic challenges related to patient experience data , and other areas of greatest interest or concern to public stakeholders. The RFI was published on May 2, 2023, and the public comment period was open until July 3, 2023. A summary of the comments was published and is available at https://www.regulations.gov by entering the following docket number: FDA-2023-N-1506. The summary was published on December 12, 2023. The input received in response to the RFI helped inform the topics for this public workshop. This virtual workshop and the input received in response to the RFI will also help inform a subsequent workshop focused on methodological challenges and will help FDA identify priorities for future work.

Workshop Materials:

  1. Workshop Agenda
  2. Workshop Slides
  3. Workshop Recording- part 1
  4. Workshop Recording- part 2
  5. Workshop Recording- part 3

Public Docket:

Stakeholders are invited to submit comments through the public docket. The public docket will close February 11, 2025. 

Related Information:

CDER Patient-Focused Drug Development

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