Date of Publication: 20-May-2026
INTELLIGENCE OVEERVIEW
Agency: USFDA
The U.S. Food and Drug Administration (FDA) has issued a revised guidance titled “Assessing the Effects of Food on Drugs in INDs and NDAs — Clinical Pharmacology Considerations” (May 2026, Revision 1), providing updated recommendations for evaluating food-drug interactions during drug development.
Food can significantly influence the absorption and systemic exposure of orally administered drugs, potentially affecting both efficacy and safety. The updated guidance highlights the importance of understanding these interactions early in development to support optimal dosing strategies and labeling recommendations.
The FDA recommends that sponsors conduct food-effect (FE) studies for new oral drug products, including immediate-release, modified-release, and fixed-dose combination products. High-fat meal studies should generally be performed early in development, while additional low-fat meal studies may be considered where clinically relevant.
The guidance also outlines considerations related to study design, patient selection, pediatric formulations, soft-food administration, model-informed drug development approaches, and labeling requirements. Sponsors are encouraged to engage with the FDA early to ensure appropriate study strategies and regulatory alignment.
This update aims to improve consistency in food-effect assessments and support safer, more effective use of oral medications throughout their lifecycle.
KEYWORDS: Drug Bioavailability, Clinical Pharmacology Guidance, Clinical Trial Dosing Strategies
REFERENCES: https://www.fda.gov/media/121313/download https://www.fda.gov/regulatory-information/search-fda-guidance-documents/assessing-effects-food-drugs-inds-and-ndas-clinical-pharmacology-considerations