FDA Issues Updated Guidance on Food-Effect Studies for IND and NDA Submissions

Regulatory affairs teams submitting orally administered drug products under INDs or NDAs now have a revised framework to work against: CDER has issued updated guidance on food-effect (FE) studies, superseding the portion of the December 2002 guidance that previously governed this area under 21 U.S.C. 355 (section 505 of the FD&C Act).

The new guidance, issued under docket number FDA-2017-D-6821, applies specifically to sponsors planning FE studies for orally administered products and covers pharmacokinetic considerations relevant to IND and NDA submissions and their supplements. It does not carry forward all content from the 2002 document; the 2002 guidance has been split across three separate instruments, and teams relying on the original as a single reference will need to update their internal SOPs accordingly.

Fed bioequivalence (BE) study requirements for ANDAs now sit in the August 2021 guidance, Bioequivalence Studies with Pharmacokinetic Endpoints for Drugs Submitted Under an ANDA. Fed comparability study recommendations have been relocated to the April 2022 guidance, Bioavailability Studies Submitted in NDAs or INDs, General Considerations. For QA and regulatory leads managing multi-pathway submissions, the cross-reference burden across these three documents is a practical compliance consideration, not a formality.

The split structure signals CDER's intent to maintain more granular, pathway-specific guidance rather than consolidated documents, a pattern consistent with the agency's recent approach to bioavailability and bioequivalence frameworks. Submission teams should verify that study protocols, clinical pharmacology sections, and module 2 summaries reference the correct current guidance for each application type.

Comments on the guidance may be submitted at any time via the online docket portal or in writing to FDA's Dockets Management office, referencing docket number FDA-2017-D-6821, per 21 CFR 10.115(g)(5).

The measurable checkpoint for most NDA sponsors will be confirming that FE study designs and data packages already in preparation align with CDER's current expectations before the next submission cycle.

Source: FDA Center for Drug Evaluation and Research via FDA.gov Guidance Documents feed, May 20, 2026.