FDA Draft Guidance on Incorporating Patient Preference Information

On Sept. 3, the FDA issued a draft guidance “Incorporating Voluntary Patient Preference Information over the Total Product Life Cycle.”

The guidance, when finalized, is intended to provide recommendations on how patient preference information might be collected and shared with the FDA and potentially be considered in FDA decision-making processes. It also provides recommendations on designing patient preference studies that may provide reliable scientific evidence. On Oct. 15, 2024, the FDA will host a webinar for industry and other parties interested in learning more about the draft guidance.

Comments should be submitted under docket number FDA-2015-D-1580 at www.regulations.gov by Dec. 5, 2024, to ensure the FDA considers comments before it begins work on the final version of the guidance.