FDA revises its GLP compliance program for nonclinical laboratories
FDA GLP compliance program 7348.808 was revised October 6, 2026 for OECD reporting. What it directs FDA investigators to check on calibration.
ICH adopts E6(R3) Annex 2 and publishes a consolidated GCP guideline
ICH E6(R3) Annex 2 reached Step 4 on June 3, 2026 and applies in the EU from January 15, 2027. What E6(R3) data governance means for calibration records.
FDA reissues its final guidance on bioanalytical method validation for biomarkers
FDA reissued its bioanalytical method validation for biomarkers guidance in April 2026, with ICH M10 as the starting point for biomarker assays.
European Commission consults on revised Annex 11, Chapter 4 and a new AI Annex 22
EU GMP Annex 11 revision, new AI Annex 22 and revised Chapter 4: consultation closed October 2025; final texts targeted for Q4 2026.
FDA notifies pharmaceutical companies that certain Raptim Research studies are unacceptable
FDA notifications on data integrity: certain Raptim Research studies were found unacceptable in March 2025. What the findings mean for calibration records.
FDA issues ICH Q2(R2) and Q14 as final guidance on analytical procedures
Date: March 2024 FDA’s Center for Drug Evaluation and Research issued ICH Q2(R2), Validation of Analytical Procedures, and the companion ICH Q14, Analytical Procedure Development, as final guidance in March 2024. Q2(R2) replaces the 2005 text with a broader framework that covers the reportable range, calibration model selection, and the validation of spectroscopic and multivariate […]