FDA Issues 2 Draft Guidances for Industry, “Assessing the Effects of Food on Drugs in INDs and NDAs — Clinical Pharmacology Considerations” and “Bioavailability Studies Submitted in NDAs or INDs — General Considerations”

Guidance for Industry

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1. Draft Guidance for Industry, “Assessing the Effects of Food on Drugs in INDs and NDAs — Clinical Pharmacology Considerations”

Today, the FDA published a draft guidance for industry entitled, “Assessing the Effects of Food on Drugs in INDs and NDAs — Clinical Pharmacology Considerations.” This draft guidance provides recommendations to sponsors planning to conduct food-effect (FE) studies for orally administered drug products as part of investigational new drug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 NDAs. 

This guidance revises and replaces part of the 2002 FDA guidance for industry entitled, “Food-Effect Bioavailability and Fed Bioequivalence Studies.” Other parts are covered in two separate guidances: Information on fed bioequivalence (BE) studies for ANDAs is included in the FDA guidance for industry entitled, “Bioequivalence Studies with Pharmacokinetic Endpoints for Drugs Submitted Under an ANDA” and recommendations concerning relative bioavailability assessment are described in the FDA guidance for industry entitled, “Bioavailability Studies Submitted in NDAs or INDs — General Considerations.”

2. Draft Guidance for Industry, “Bioavailability Studies Submitted in NDAs or INDs — General Considerations”

Today, the FDA published a draft guidance for industry entitled, “Bioavailability Studies Submitted in NDAs or INDs — General Considerations.” This draft guidance provides recommendations for evaluation of bioavailability (BA) for orally administered drug products in investigational new drug applications (INDs), new drug applications (NDAs), and NDA supplements.  

This guidance contains advice on how to meet the BA requirements set forth in 21 CFR part 320 as they apply to dosage forms intended for oral administration. The guidance is also applicable to non-orally administered drug products when it is appropriate to rely on systemic exposure measures to determine the BA of a drug (e.g., transdermal delivery systems and certain rectal and nasal drug products). The guidance provides advice on conducting relative BA studies during the IND period for a drug intended to be submitted for approval in an NDA and bioequivalence (BE) studies during the post approval period for certain changes to drug products. 

 

When finalized, this guidance will revise and replace the FDA’s March 2014 draft guidance for industry entitled, “Bioavailability and Bioequivalence Studies Submitted in NDAs or INDs — General Considerations,” which addresses BA or BE studies for INDs, NDAs, and NDA supplements.