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Combo Product Safety: US FDA Rule On Post-Market Reporting Nears Finalization

 
• By Michael Cipriano

Industry is eagerly awaiting guidance on combination products, and after seven years the adverse-event reporting regulation may be at top of the agency’s queue.

US FDA's proposed rule on post-market safety reporting for combination products appears to finally be making its way to the top of the queue, with the agency acknowledging that it is among the next steps in modernizing the combination products review program.

The rule – which was first proposed in 2009 – aims to clarify post-marketing safety reporting requirements for such products by spelling out the types of alerts that...

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More from North America

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• By Natasha Barrow

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FDA Halts Acceptance Of Chinese Lab Data Due To Accuracy Issues

 
• By Elizabeth Orr

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.