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Newsletter

FDA’s New QSMR Inspection Program (CP 7382.850) — And How It Differs from QSIT

On February 2, 2026, FDA formally implemented Compliance Program 7382.850 – Inspection of Medical Device Manufacturers, aligned with the new Quality Management System Regulation (QMSR).  This program replaces the prior inspection model that industry knew well: QSIT (Quality System Inspection Technique). For device manufacturers, regulatory professionals, and quality leaders, understanding this shift is critical. This […]
February 24, 2026

The Overlooked Pharmacovigilance Risk in 2026: When “Non-PV” Vendors Perform PV Activities

In 2026, pharmacovigilance systems are more digital, more decentralized, and more interconnected than ever. Yet one risk continues to be underestimated across organizations — especially during inspections. It’s not always your core safety vendor. It’s the vendor that was never labeled “PV” in the first place. We’re talking about organizations that interact directly with patients […]
February 24, 2026

What FDA’s 2025 Warning Letters Reveal About Current GMP Compliance Risks

FDA’s 2025 warning letters are out — and they send a very clear message: the agency is back in force on GMP enforcement, and the fundamentals are where firms continue to stumble. Whether your operations are sterile or non-sterile, API or finished dose, the issues that keep showing up are not random — they point […]
January 15, 2026

Verifying CRO Compliance With SUSAR Reporting Timelines and Determination of Expedited vs. Standard Reporting

Suspected Unexpected Serious Adverse Reactions (SUSARs) represent one of the highest regulatory risk areas in clinical development. Health Authorities (HAs) globally, including the FDA, EMA, and national competent authorities, impose strict timelines and documentation expectations for SUSAR identification, assessment, and reporting. Sponsors frequently delegate pharmacovigilance (PV) case processing and regulatory reporting activities to Contract Research […]
January 15, 2026