Guidance Snapshots are a communication tool and are not a substitute for the guidance document.

To learn more about assessing the effects of food on drugs, read the guidance: 

https://www.fda.gov/regulatory-information/search-fda-guidance-documents/assessing-effects-food-drugs-indsand-ndas-clinical-pharmacology-considerations

www.fda.gov

Assessing the Effects of Food on Drugs in INDs and NDAs 

Clinical Pharmacology Considerations Final Guidance

Dissolved Active Pharmaceutical Ingredient (API) Assessing the Effects of 

Food on Drugs in INDs and NDAs -

Clinical Pharmacology 

Considerations

Why is this guidance important?

Food can affect the absorption of 

drugs from the gastrointestinal 

(GI) tract. This can impact plasma 

levels of the drug resulting in 

changes in safety and efficacy. 

Sponsors should assess 

the effects of food on the 

pharmacokinetics (PK) 

of oral investigational 

drugs to inform the drug 

development program 

and product labeling.

What Is Covered in This Guidance?

A final guidance has been issued providing recommendations 

on the conduct of food effect (FE) studies for orally 

administered drug products.
Guidance Snapshots are a communication tool and are not a substitute for the guidance document.

To learn more about assessing the effects of food on drugs, read the guidance: 

https://www.fda.gov/regulatory-information/search-fda-guidance-documents/assessing-effects-food-drugs-inds-andndas-clinical-pharmacology-considerations

www.fda.gov

Sponsors should assess the effect of food on the PK of a new drug early in its development 

to guide the overall drug development program and final product labeling. Sponsors should 

test the effect of food on a new drug in clinical trials before conducting the pivotal safety and 

efficacy trials to provide informed decisions regarding dosing with respect to food.

WHEN

Conduct a pilot study to provide 

a preliminary assessment of the 

effect of a high-fat meal on the 

systemic exposure of the drug.

Use a randomized, balanced, 

single-dose, two-treatment 

(i.e., fed versus fasted), twoperiod, crossover design.

Conduct FE studies in an adequate 

number of healthy subjects, unless 

precluded by safety concerns, to 

sufficiently characterize the food 

effect. 

Use the clinically recommended 

dose in the pivotal FE study; when 

several doses of a drug that exhibit 

linear PK will be marketed, use the 

highest clinically recommended 

dose unless safety concerns 

necessitate a lower dose. 

Incorporate specific fasting and 

fed recommendations, including 

meal content, timing, and water 

restrictions, into study design.

Conduct an FE study with a 

high-fat meal for all orally 

administered drugs. When a 

significant FE is observed with a 

high-fat meal, evaluation of other 

meal types—such as a low-fat 

meal—can be performed to 

further inform labeling.

ASSESSING

FOOD 

EFFECTS

DOSE

SUBJECTS

FE PILOT

STUDIES

MEAL

TYPES

ADMINISTRATION 

CONDITIONS

FE 

DEFINITIVE 

STUDIES

Food can have a significant impact on the safety or efficacy of orally administered drug 

products. In some cases, food can be used to improve tolerability of a drug that causes GI 

discomfort. Well-conducted FE studies can inform how, when, and why drugs should or 

should not be administered with food.

The guidance provides general considerations for designing FE studies, as well as recom- WHAT mendations for data analysis and labeling. 

WHY
Guidance Snapshots are a communication tool and are not a substitute for the guidance document.

To learn more about assessing the effects of food on drugs, read the guidance: 

https://www.fda.gov/regulatory-information/search-fda-guidance-documents/assessing-effects-food-drugs-inds-and-ndas-clinicalpharmacology-considerations

To see additional Guidance Snapshots, check out the pilot program: 

https://www.fda.gov/drugs/guidances-drugs/guidance-snapshot-pilot

www.fda.gov

Guidance Recap Podcast – Hear Highlights Straight From FDA Staff

Speakers: Vikram Arya, PhD, FCP, Associate Director for Therapeutic Review 

in the Division of Infectious Disease Pharmacology, and Brian Booth, PhD, 

Director of the Division of Cancer Pharmacology I.

Background About the Guidance 

This guidance finalizes draft guidance issued in February 2019. 

It revises and replaces the part of the 2002 FDA guidance titled 

Food-Effect Bioavailability and Fed Bioequivalence Studies. 

Information on fed bioequivalence studies to be submitted in 

abbreviated new drug applications (ANDAs) is now found in the 

FDA guidance for industry titled Bioequivalence Studies with 

Pharmacokinetic Endpoints for Drugs Submitted Under an ANDA. 

Specific recommendations concerning fed comparability trials are 

now described in the FDA guidance for industry titled Bioavailability 

Studies Submitted in NDAs or INDs — General Considerations.

Guidance Recommendations Apply Throughout the Drug Development Timeline 

During Clinical Development: Food-drug interactions can have a significant impact on the safety and 

efficacy of a drug. These effects can be manifested in different ways. 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. During 

new drug development, FE studies are conducted to determine if, and to what extent, food impacts the 

systemic exposure of the drug; whether food changes the variability of the systemic exposure of the 

drug; and if the effect of food is different across meals with varying fat or caloric contents.

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