> ## Content Index
> Fetch the complete content index at: https://www.fdaweb.com/llms.txt
> Use this file to discover other available public pages before exploring further.

# Stakeholders Comment on Patient Preference Guide
- URL: https://www.fdaweb.com/stakeholders-comment-on-patient-preference-guide/
- Published: 2024-12-11T12:00:00.000Z
- Updated: 2026-09-14T14:49:12.000Z
- Author: David McFarland
- Tags: Drugs, Devices, #legacy-id-D5158343

Four industry stakeholders are recommending changes to an FDA draft guidance on incorporating voluntary patient preference information over the total product lifecycle. AbbVie [says](https://www.regulations.gov/comment/FDA-2015-D-1580-0054?ref=fdaweb.com) it partners with patients, patient organizations, caregivers, and clinicians to ensure that individual experiences, perspectives, needs, and priorities are part of the clinical development process.

The International Society for Pharmacoepidemiology [commends](https://www.regulations.gov/comment/FDA-2015-D-1580-0050?ref=fdaweb.com) FDA’s continued recognition of the importance of patient preference data and its potential to inform the development and evaluation of medical devices and medicines, and the agency’s effort to improve the science and support medical device and pharmaceutical manufacturers.

In its comment [letter](https://www.regulations.gov/comment/FDA-2015-D-1580-0052?ref=fdaweb.com), Novartis says it would be helpful to devote a section in the guidance to recommended statistical design and analysis methods. It also calls on FDA to stress more strongly the need for a statistical analysis plan at the pre-analysis stage.

AdvaMed [provides](https://www.regulations.gov/comment/FDA-2015-D-1580-0049?ref=fdaweb.com) specific line-by-line comments, as do the other three stakeholders.