The final guideline published by the FDA on Assessing the Effects of Food on Drugs in INDs and NDAs is now available in DIDB Resource Center. Please note that you must be signed in to access.
This guidance revises and replaces part of the 2002 FDA guidance entitled Food-Effect Bioavailability and Fed Bioequivalence Studies (December 2002).
This guideline provides recommendations to sponsors planning to conduct food-effect (FE) studies for orally administrated drug products under INDs, to support 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 335).
Note that clinical food effects data are curated by our DIDB Editorial Team. They are entered in DIDB as single drug PK studies with no precipitant. Changes in AUC, CL, and plasma concentrations are calculated for the fed state versus the control fasted state.