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# Create One PPI Guidance for all Products: Novartis
- URL: https://www.fdaweb.com/create-one-ppi-guidance-for-all-products-novartis/
- Published: 2023-06-08T12:00:00.000Z
- Updated: 2026-09-14T18:38:02.000Z
- Author: David McFarland
- Tags: Drugs, Devices, #legacy-id-D5154648

Novartis says a current FDA guidance on patient preference information (PPI) pertains only to medical device development. “A common guidance on PPI that applies to devices, drugs, and drug-device combinations would help medicine developers in consistently applying the same principles and methods throughout medical product development,” the company says in a comment [letter](https://www.regulations.gov/comment/FDA-2015-D-1580-0033?ref=fdaweb.com).

The company also says it would be interested to see examples from the agency of instances when PPI had an impact on or informed regulatory decision-making. “Highlighting such examples would encourage manufacturers to invest more in this approach in the future,” Novartis writes.

The letter also provides company responses to specific questions FDA posed as well as additional comments.

Patient Focused Medicines Development [says](https://www.regulations.gov/comment/FDA-2015-D-1580-0030?ref=fdaweb.com) it “commends FDA for its efforts to clarify the main considerations needed to design and demonstrate a fit-for-purpose PPI study, key information for inclusion in premarket submissions that include PPI, and generalized examples of PPI studies that may help support regulatory decisions.” The advocacy group says the engagement of patients in the design and generation of patient preference studies and the use of patient preference information must be promoted and adhered to by all stakeholders and accurately reflect what is described in guidance and policy documents.