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Industry Seeks More Clarity Following Combo Product GMP Final Rule

FDA’s final regulation outlines which manufacturing system requirements apply to products that have drug, device and/or biologic components. An industry coalition says key details need to be filled in by FDA with guidance.

The industry Combination Products Coalition generally agrees with the content of FDA’s final rule on combination product current good manufacturing practices, but says the rule lacks details on implementation and scope.

FDA’s final regulation, issued Jan. 22, outlines which manufacturing system requirements apply to products that have drug, device and/or biologic components. The agency says the final rule is...

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