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Expert Articles

Compliance with ISO 14971 Application of risk management to devices can be challenging, especially when standards can change. However, because risk management occurs for the entire life cycle of a device, understanding the steps involved and applying them appropriately is important. General Considerations ISO 14971 is an international standard that applies to the risk management […]

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As patents for older biologicals expire, a new market for biosimilars has opened.  This new market allows manufacturers to market less expensive alternatives for patients. Despite this, the Food and Drug Administration (FDA) had done little to establish a mechanism for biosimilar approval until relatively recently, and only a few biosimilars have been approved in […]

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The Anatomy of a Mock Inspection Introduction Inspections by the Food and Drug Administration are challenging. If the company fails, the Food and Drug Administration can issue them a warning letter or, in extreme cases, shut down the company’s operations entirely. Because the consequences of noncompliance are serious, many executives would like to know where […]

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