Author

Khelin N. Aiken

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FDA Food Safety Modernization Act Proposed Rule to Advance Traceability of Foods Key Takeaways On September 23, 2020, the Food and Drug Administration (FDA, the Agency) released its proposal to establish additional recordkeeping requirements for those that manufacture, process, pack, or hold foods on the Food Traceability List by collecting Key Data Elements (KDEs) associated with different Critical Tracking Events (CTEs). If finalized, this rule has the potential to impact a significant number of organizations…

Responding to and mitigating the impact of the COVID-19 pandemic has catapulted its way to the top of every business operation consideration in each industry and the global market in general. One of the more vulnerable operations for the pharma and biotech industry that we anticipate will continue to require adept and innovative efforts to mitigate impact is the medical product supply chain. Disruptions to medical product supply will not only affect public health, but…