Each week, the regulatory developments that matter across bioanalytical, bioequivalence, clinical trials and quality, traced to the primary source. Newest at the top; select a week to open the issue.
Nine selected developments turn a high-volume week into a traceable clinical, quality and regulatory briefing.
Nine selected developments connect product quality, patient safety, clinical evidence and regulatory readiness.
Nine selected developments show where safety, programme execution and regulatory evidence now require action.
Nine selected developments connect patient safety, pivotal evidence, manufacturing readiness and submission quality.
W31 opens with USP-EDQM pharmacopoeial harmonisation and reliance plus an early Faron BEXMAB survival readout — an opening baseline, still unfolding.
The EMA's July approvals, a $1.5bn tumour-MRD lab consolidation and Samsung's peptide-CDMO tender meet a biosimilar evidence rethink, new generic-drug tariffs, a fresh FDA data-integrity cluster and Ipsen's failed Phase III biliary-atresia trial — each traced to its primary source.
Evidence, audit trails, training, suppliers and post-market commitments becoming day-to-day quality work, not last-minute preparation — each traced to its primary source.
FDA moves on real-time clinical trials and a reset evidence standard, a data-integrity warning letter to Sanofi's Waterford site, and the EMA mid-year GMP work plan and PRAC safety review.
A data-integrity audit on every FDA pre-approval inspection, the MHRA on AI-written responses, and the European Pharmacopoeia in force across 39 countries.
CHMP moves to revoke a marketed product on trial data-integrity grounds; FDA drug warning letters rise 59% year on year.
Nine developments across quality, clinical trials and regulatory, each traced to its primary source.
Nine developments across quality and clinical trials, each traced to its primary source.
Nine developments across quality, clinical trials and regulatory, each traced to its primary source.
Nine developments across quality, clinical trials and regulatory, each traced to its primary source.
Nine developments across clinical trials, bioequivalence and regulatory, each traced to its primary source.
Nine developments across quality, clinical trials and regulatory, each traced to its primary source.
Nine developments across quality, clinical trials, bioequivalence and bioanalytical, each traced to its primary source.