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Combo Products GMP Guidance Fills In Gaps On Drug-Delivery Device Compliance

FDA has delivered a draft current good manufacturing practices guidance for combination products, providing details and examples on how the agency regulates drug delivery devices and other drug/device, drug/biological and drug/device/biological products.

A draft companion guidance

to FDA’s combination products rule provides examples and detailed instructions for compliance with agency good manufacturing practice rules for drug delivery devices and other

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