Author: [AUTHOR] Published on 7/1/2022 12:00:00 AM
US Food and Drug Administration Announces Availability of a Final Guidance Entitled Assessing the Effects of Food on Drugs in INDs and NDAs — Clinical Pharmacology Considerations
On June 24, 2022, the US Food and Drug Administration (FDA) announced the availability of a final guidance for industry entitled
Assessing the Effects of Food on Drugs in INDs and NDAs — Clinical Pharmacology Considerations. This final guidance provides recommendations to sponsors planning to conduct food-effect studies for orally administered drug products under investigational new drug applications (INDs) to support new drug applications (NDAs) and supplements to these applications for drugs being developed under section 505 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355).
Food-drug interactions can have a significant impact on the safety and efficacy of orally administered drug products and can manifest in different ways. In some cases, co-administration of an orally administered drug with food can increase the systemic exposure of the drug, potentially leading to an increased pharmacologic effect impacting efficacy and/or safety findings. In other cases, administration of an orally administered drug with food can lower the systemic absorption of a drug, thereby reducing the efficacy. Hence, assessing the effect of food on the absorption of an orally administered drug contributes to the optimization of the safety and efficacy of the product and helps provide adequate instructions for drug administration in relation to food.
This guidance provides recommendations to sponsors on the conduct of pharmacokinetic studies to assess the effect of food on the systemic exposure of the drug to determine: (1) if, and to what extent, food impacts the systemic exposure of the drug; (2) whether food changes the variability of the systemic exposure of the drug; and (3) if the effect of food is different across meals with different fat or caloric contents. This guidance also provides sponsors with recommendations on data analysis and labeling.
The “Assessing the Effects of Food on Drugs in INDs and NDAs — Clinical Pharmacology Considerations” guidance is available at
https://go.usa.gov/xJf5K. Please refer to the final guidance for more details. To support transparent communication and dissemination of FDA guidance documents, FDA also provides Guidance Snapshots and podcasts as communication tools to provide highlights from guidance documents using visuals and plain language. Please find the Guidance Snapshot and podcast for this final guidance here:
https://www.fda.gov/drugs/guidances-drugs/guidance-snapshot-pilot.
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This communication was prepared by Office of Clinical Pharmacology, Office of Translational Sciences, CDER, FDA.
