BEBAC  Ing. Helmut Schütz


Draft Guidance for Industry: Bioequivalence Studies with Pharmacokinetic Endpoints for Drugs Submitted Under an ANDA

On 4 Dec 2013 the FDA’s Center for Drug Evaluation and Research (CDER) published the drafted guidance for a 90-day public consultation period (i.e., until 5 March 2014).

This guidance provides recommendations to applicants planning to include bioequivalence (BE) information in abbreviated new drug applications (ANDAs) and ANDA supplements. The guidance describes how to meet the BE requirements set forth in the Federal Food, Drug, and Cosmetic Act (FD&C Act) and FDA regulations. The guidance is generally applic­able to dosage forms intended for oral administration and to non-orally administered drug products in which reliance on systemic exposure measures is suitable for documenting BE (e.g., transdermal delivery systems and certain rectal and nasal drug products). The FDA believes that the guidance will also be useful when planning BE studies intended to be conducted during the postapproval period for certain changes in an ANDA.

This guidance revises and replaces parts of two FDA guidances for industry, relating to BE and fed BE studies to be submitted in ANDAs. This guidance does not address bioavail­ability (BA), BE, and food effect studies in investigational new drug applications (INDs) and new drug applications (NDAs). A separate guidance will soon be available that will address BA and BE studies for INDs, NDAs, and NDA supplements. FDA has deter­mined that separating guidances according to application type will be beneficial to applicants.

Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance, submit electronic comments on the draft guid­ance by March 05, 2014 to
See also “Tips for Submitting Effective Comments”.