Scholar Rock's SMA drug was rejected over a facility inspection finding. The fix wasn't fixing the facility — it was building a redundant one.

How to build an EU GMP Annex 1 contamination control strategy: the 16 CCS elements, PUPSIT, APS, common inspection gaps, and a step-by-step approach.

What ICH Q9(R1) changed in quality risk management: subjectivity, formality, risk-based decisions and product availability, with worked examples and a practical framework.

Where nitrosamine and NDSRI control stands after FDA's August 2025 progress report change: CPCA limits, EMA Article 5(3) Q&A, mitigation and submission pathways.

FDA's voluntary Quality Management Maturity Program is quietly building toward a real quality rating system. Here's what it measures and what's at stake.

FDA decides Aug 5 on Moderna's mRNA-1010 flu vaccine. Here's the trial data, the competitive landscape, and why the decision matters beyond flu shots.

Accelerated approval gets discussed constantly in the abstract — surrogate endpoints, confirmatory trials, the theoretical risk of a drug reaching market on thinner evidence. A decision earlier this month gives a live, current example of what that pathway actually looks like in practice, end to end. On July 7, 2026, FDA granted accelerated approval to Vera Therapeutics' atacicept-vymj, to be marketed as Trutakna, for reducing proteinuria in adults with primary IgA nephropathy