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    FDA Issues Its Final Rule for Combination Product Quality Systems

    This article is part of a series on the regulation of combination products in the US. 1-10 On 22 January 2013, the US Food and Drug Administration (FDA) published the long-anticipated final rule, Current Good Manufacturing Practice Requirements for Combination Products 11 to clarify regulatory requirements for quality systems used to design, develop and manufacture combination products, and to help ensure consistent and appropriate application and enforcement of these...
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    Changes Coming to FDA Quality System Requirements for Prefilled Injection Devices

    This article reviews the current state of the development of quality system requirements for combination products, in particular prefilled drug delivery devices. As part of a series on US Food and Drug Administration (FDA) regulation of combination products, 1-9 it discusses industry's response to FDA's proposed rule on quality systems for combination products and how manufacturers of combination products should prepare for compliance with the anticipated final rule and ...