Compare FDA BA/BE data integrity and ICH E6(R3) GCP
How to read this page
- How they are linked says why these two documents are connected. Links explained
- Side by side places facts from each record together, so you can see status, weight and dates at a glance.
- It does not compare content. It does not say which is stricter. Read the official texts for that.
How they are linked
- FDA BA/BE data integrity is related to ICH E6(R3) GCP · Source Unverified link
Side by side
| FDA BA/BE data integrity | ICH E6(R3) GCP | |
|---|---|---|
| Authority | FDA | ICH |
| Legal weight | Guidance & Q&A | Guidance & Q&A |
| Status | Draft | Final |
| Last verified | Not yet | Not yet |
| Summary | Draft FDA guidance for applicants and testing sites on achieving and maintaining data integrity in the clinical and bioanalytical parts of bioavailability and bioequivalence studies. | Revised ICH guideline on good clinical practice. FDA says it adds flexible, risk-based approaches and embraces innovations in trial design, conduct and technology. |
| Lifecycle |
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| Source | Official text Source: FDA. Public domain. | Official text Source: ICH. |
These facts are placed side by side from each record. This page does not say which is stricter or whether requirements differ. Read the official texts.