FDA Revises Guidance on Testing Effect of Food on Drugs

The FDA released new draft guidance on assessing the effects of food on drugs as part of investigational and new drug applications.

Clinical trial sponsors should assess the effect of food on a new drug’s pharmacokinetics early in the development stages and should test the effect of food in clinical trials before conducting pivotal safety and efficacy trials, the agency says.

Sponsors should conduct a pivotal food-effects trial using the to-be-marketed formulation in cases where the formulation is different than the clinical trial formulation used in the pivotal safety/efficacy trials. When food adversely affects a drug’s safety or efficacy, requiring fasted dosing, the sponsor should conduct studies to determine a realistic time interval between drug dosing and meals, the guidance states.