Data Integrity for In Vivo Bioavailability and Bioequivalence Studies (draft)

Context and history

This draft guidance dates from April 2024. FDA says it gives recommendations for achieving and maintaining data integrity in bioavailability and bioequivalence studies. It is marked not for implementation.

FDA explains the concern: these studies now involve more firms and more complex products, so data pass through more hands. Applicants can contract out the work, but FDA says the ultimate responsibility for the quality and integrity of the study data stays with the applicant.

Who and what it applies to

Applicants and testing site management for clinical and bioanalytical parts of those studies, supporting INDs, NDAs and ANDAs.

What it contains

Recommendations for applicants

Ensure integrity and confidentiality of data, and implement a system to manage data quality through all stages of a study. Applicants stay responsible when they use testing sites.

Recommendations for testing site management

Recommendations for those running the clinical and bioanalytical work, including elements of a quality management system.

Key points

• Responsibility stays with the applicant, even when work is contracted out.
• Its data integrity thinking is applied to studies, not manufacturing.
• It covers electronic systems development and use during a study.
• It is a draft, not for implementation.

In practice

General reading, not advice. This is drafted with AI and may not fit your situation. It does not replace the official text, your own quality system or qualified advice, and an inspector may take a different view.

• If you use a contract research organisation, check your oversight and audit evidence against this draft.
• Contract research organisations can use it as a self-assessment.

Read from the source document on 1 Nov 2026. This is our own description, not the official text. Check the full dated history in the change log below.