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# Food Effects Guidance
- URL: https://www.fdaweb.com/food-effects-guidance/
- Published: 2022-06-23T12:00:00.000Z
- Updated: 2026-09-14T17:49:48.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5152144

FDA has published a guidance, *Assessing the Effects of Food in INDs and NDAs—Clinical Pharmacology Considerations*, with recommendations for sponsors planning to conduct food-effect (FE) studies for orally administered drug products under INDs to support NDAs and supplements to those applications. The [document](https://www.fda.gov/media/121313/download?ref=fdaweb.com) revises and replaces part of a 2002 guidance.

The contents of the guidance are Introduction, Background, Recommendations for FE Studies, Considerations for Designing FE Studies, Other Considerations, Data Analysis and Labeling, and three Appendices.