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Examining the Drug Supply Chain – How the Public Health Emergency Impacts DSCSA

The Drug Supply Chain Security Act was intended to enhance the safety and security of the pharmaceutical distribution supply chain – but in a few short months, everything has changed. Our Food, Drug & Device/FDA Group...more

FDA Temporarily Postpones Routine Domestic Inspections

Our FDA Compliance & Enforcement Team examines the Food and Drug Administration’s decision to temporarily postpone routine surveillance domestic inspections in the wake of the continuing coronavirus (COVID-19) outbreak....more

New Guidance Refines FDA’s Thinking on Data Integrity

Our Food, Drug & Device/FDA Group breaks down the new Food and Drug Administration guidance on data integrity for current good manufacturing practices (CGMPs) and what it means for the drug industry....more

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