On January 31, 2022, the U.S. Food & Drug Administration (FDA) published a notice in the Federal Register announcing the availability of a final guidance for industry and FDA staff entitled “Principles of Premarket Pathways for Combination Products”. The final guidance is available on the FDA’s website. It provides FDA’s current thinking on principles for premarket review of combination products. It finalizes previously available draft guidance, dated February 6, 2019, which altogether are part of FDA’s efforts to implement section 3038 of the 21st Century Cures Act expressly addressing combination products. The final guidance is nonbinding.
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Is Your Data Supply Chain Ethical? Don’t Restrict Due Diligence to Physical Operations.
This article was originally published in Corporate Compliance Insights.
Both your company’s data supply chain and its physical version have fundamentally similar business risks. Given the consequences of unethical practices along both, enterprises can no longer ignore how data is sourced, how it is managed or where it is going.
While many organizations go to great lengths to monitor their physical supply chain, their data supply chain often gets short shrift. For any company interacting with large sets and various streams of information, this can represent a significant exposure to risk.
Since the first investigation under the U.S. FCPA concerning a third party acting on behalf of a U.S. company was initiated nearly 40 years ago, upholding integrity in global supply chains has garnered attention. Rightfully so, as compounding risks in physical production and movement of goods abound upstream (e.g., forced labor, conflict materials, environmental impact) and downstream (e.g., bribery, fraud, misuse).
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