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# Biological Promotion Q&A Guidance
- URL: https://www.fdaweb.com/biological-promotion-q-a-guidance/
- Published: 2024-04-24T12:00:00.000Z
- Updated: 2026-09-14T14:29:04.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5156837

FDA has published a draft guidance, *Promotional Labeling and Advertising Considerations for Prescription Biological Reference Products, Biosimilar Products, and Interchangeable Biosimilar Products — Questions and Answers*, to address questions firms may have when developing FDA-regulated promotional labeling and ads for specified prescription biological products. The [document](https://www.fda.gov/regulatory-information/search-fda-guidance-documents/promotional-labeling-and-advertising-considerations-prescription-biological-reference-and-biosimilar?ref=fdaweb.com) replaces a 2/2020 draft guidance with changes that include additional recommendations and an example for interchangeable biosimilar products. FDA says editorial changes also were made to improve clarity.

“This revised draft guidance fulfills the Biosimilar User Fee Amendments of 2022 commitment to publish draft guidance on promotional labeling and advertising considerations for interchangeable biosimilar products,” FDA says.