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 drug/device, drug/biological and drug/device/biological products.

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Commission’s Flora Giorgio Says Simplification And Safety Are Key In Evolving EU Regs

 

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FDA Halts Acceptance Of Chinese Lab Data Due To Accuracy Issues

 
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The FDA has stopped accepting data from two Chinese labs due to accuracy issues. Mid-Link and SDWH have been flagged for potentially falsified results and other misconduct. This decision, which follows months of discussions and warnings, emphasizes the FDA's commitment to ensuring data integrity in medical device submissions.