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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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• By Natasha Barrow

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ConcertAI Launches Generative AI-Powered Precision Suite

 
• By Natasha Barrow

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More from North America

Get Ready For International Harmonization Before Approaching QMSR Deadline, Says Regulatory Expert

 
• By Brian Bossetta

During MD&M East last week, regulatory consultant Darren Reeves reminded device manufacturers that the time to get ready to comply with the new Quality Management System Regulation is now.

Zika Virus Test Among 4 New FDA Device Classifications

 
• By Elizabeth Orr

The FDA plans to announce class II status for four new device types, including tests for the Zika virus and genetic condition Fragile X. This follows earlier announcements and highlights a trend toward diagnostic classifications. The classifications are considered deregulatory, meaning they will hel

FDA Draft Guidance Introduces Electric Submission For Q-Sub Process

 
• By Brian Bossetta

The US FDA says its updated draft guidance represents one of several steps the agency is taking to develop electronic submission templates for the medical device industry. The document introduces stakeholders to currently available resources for supporting their pre-subs to the agency.