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GUIDANCE DOCUMENT

Incorporating Voluntary Patient Preference Information over the Total Product Life Cycle Draft Guidance for Industry, Food and Drug Administration Staff, and Other Interested Parties September 2024

Download the Draft Guidance Document Read the Federal Register Notice
Draft

Not for implementation. Contains non-binding recommendations.

This guidance is being distributed for comment purposes only.

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Submit Comments Online

Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the FDA considers your comment on a draft guidance before it begins work on the final version of the guidance, submit either online or written comments on the draft guidance before the close date.

If unable to submit comments online, please mail written comments to:

Dockets Management
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852

All written comments should be identified with this document's docket number: FDA-2015-D-1580

Docket Number:
FDA-2015-D-1580
Issued by:
Guidance Issuing Office
Center for Devices and Radiological Health
Center for Biologics Evaluation and Research

FDA is issuing this draft guidance to communicate when and what methods could be used to collect and submit patient preference information (PPI) across the total product life cycle. This will include helping explain when PPI may be helpful, and in what context. Without this re-issuance, sponsors and other patient preference study developers will not be aware of updated methodologies and considerations, which could result in costly studies that may not be appropriate to inform benefit-risk decision making. This update, when finalized, will provide more clarity in when and in what contexts different methods are best applied.

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