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MDR Reporting: FDA Embraces Adverse Event Summaries Under MDUFA IV, But Flouts Similar FDAAA Mandate

 
• By Shawn M. Schmitt

The US agency sends mixed signals by agreeing to accept more summarized Medical Device Reports under an upcoming law, yet ignoring a similar, watered-down requirement found in a 2007 congressional act. Two top industry attorneys weigh in.

Dictionary Series - Summary

US FDA appears to be embracing an increase in summarized Medical Device Reports from industry under the upcoming MDUFA IV user-fee agreement, while turning a cold shoulder to a more watered-down summary report requirement found in a decade-old congressional act.

Laid bare in an August draft Medical Device User Fee Amendment IV commitment letter, the agency will allow...

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Study: FDA’s Breakthrough Path Speeds Access, But Raises Safety Questions

 
• By Elizabeth Orr

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