FDA Issues Draft Guidance on Bioavailability and Bioequivalence Studies Submitted in NDAs or INDs

FDA Issues Draft Guidance on Bioavailability and Bioequivalence Studies Submitted in NDAs or INDs

On March 18, FDA issued a draft guidance that provides recommendations to applicants planning to include bioavailability ("BA") or bioequivalence ("BE") information for drug products in new drug applications ("NDAs"), investigational new drug applications ("INDs"), and NDA supplements. The guidance sets forth how applicants can satisfy the BA/BE requirements of 21 C.F.R. Part 320 as they apply to dosage forms intended for oral administration. The guidance is meant to assist applicants conducting BA/BE studies during the IND period for an NDA, as well as applicants conducting BE studies during the postapproval period for certain changes to drug products that are the subject of an NDA.

Once finalized, the guidance will revise and replace FDA's March 2003 guidance, Bioavailability and Bioequivalence Studies for Orally Administered Drug Products.

Summary of Changes to March 2003 Guidance

Revisions to the March 2003 BA/BE guidance include:

  • Expansion of the section on modified-release products;
  • Addition of a section on concomitant administration of drug products and combination drug products;
  • Addition of a section on alcoholic beverage effects on modified-release dosage forms;
  • Addition of an endogenous substance section;
  • Addition of a section on drug products with high intrasubject variability; and
  • Removal of references to BE studies conducted for ANDAs.

New Guidance Does Not Apply to ANDAs or Biologics

This guidance is designed to aid FDA's evaluation of the safety and effectiveness of a product that is the subject of an IND, NDA, or NDA supplement. Because the evaluation of BE in the generic drug context involves consideration of different types of data included in an ANDA, the approaches in this guidance may differ from similar discussions of BE in the ANDA BE Draft Guidance.

The guidance does not apply to Biologic License Applications, nor is it relevant to the abbreviated pathway for biosimilars, for which industry is still awaiting further FDA guidance.

Industry should also note that this guidance does not replace the 2002 Food-Effect Guidance with respect to studies for INDs, NDAs, and NDA supplements. However, FDA indicated that it is currently revising the 2002 Food-Effect Guidance.

Comments Should Be Submitted by May 19

To ensure that FDA considers comments before issuing the final version of the guidance, FDA encourages industry to submit comments on the draft guidance by May 19. Comments can be submitted electronically to

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Christopher M. Mikson

Emily K. Strunk

Stephanie L. Resnik

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