Assessing the Effects of Food on Drugs in Investigational New Drugs and New Drug Applications-Clinical Pharmacology Considerations; Guidance for Industry; Availability

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The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled "Assessing the Effects of Food on Drugs in INDs and NDAs--Clinical Pharmacology Considerations." This guidance provides recommendations to sponsors planning to conduct food-effect (FE) studies for orally administered drug products as part of investigational new drug applications (INDs), new drug applications (NDAs), and supplements to these applications. This guidance finalizes the draft guidance of the same title issued on February 26, 2019.