Tag: Combination Products

Healthcare, Industry News, Medical Devices, Regulatory Affairs

US FDA issues a new rule that addresses post-market safety reporting obligations for combination products

USFDA has issued a final rule establishing the post-market safety reporting requirements specifically for combination products. These regulations for drugs, devices, and biological products share many similarities, however, each set of regulations has certain unique reporting requirements, standards and timeframes based in part on the characteristics of the type of product. The FDA’s new rule […]

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