Tag
5 articles tagged fda.
FY2026 FDA warning letters keep citing the same analytical procedure gaps: HPLC audit trails, OOS handling, method validation. What Ava, Intas, Huons and Sanofi Waterford suggest for QC labs.
Three years after ICH Q13 came into force, 17 continuous-manufacturing drug approvals sit on the FDA's ledger and 72 CM technologies have joined the Emerging Technology Program - but adoption remains narrow.
The FDA's push to collect analytical laboratory quality metrics from drug manufacturers has taken a decade to become the voluntary QMM assessment. What laboratories should expect from the 2026 cycle.
FDA, EMA, and PMDA all build on ICH Q2(R2) and Q14, but their expectations for routine chemometric model upkeep, post-approval changes, and reference-method failures diverge in ways that shape submission strategy.
FDA finalized the Advanced Manufacturing Technologies designation program in January 2025. The older Emerging Technology Program handles earlier engagement; its guidance refresh is due by end-2026 under PDUFA VII.