> ## 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.

# Guidance on Drug Food Effects Studies
- URL: https://www.fdaweb.com/guidance-on-drug-food-effects-studies/
- Published: 2026-05-20T12:00:00.000Z
- Updated: 2026-09-14T13:39:37.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5161176

FDA has published a guidance, *Assessing the Effects of Food on Drugs in INDs and NDAs — Clinical Pharmacology Considerations*, with recommendations for sponsors planning to conduct food effect studies for orally administered drug products as part of INDs or NDAs and supplements to those applications. The [document](https://www.fda.gov/media/121313/download?ref=fdaweb.com) revises part of a 2022 guidance, the agency says.

The guidance contains an Introduction, Background, Recommendations for FE (Food Effect) Studies, Considerations for Designing FE Studies, Other Considerations, Data Analysis and Labeling, and two Appendices on the composition of high-fat and low-fat meals.