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Podcast: FDA’s Inspection ‘Program Alignment,’ New Guidance Docs Top QA/RA Hotspots In 2017

 
• By Shawn M. Schmitt

US FDA has reportedly selected three cities that will be home to new agency divisions dedicated to coordinating inspections of device manufacturers under its “program alignment” inspection initiative. This development is just one of many that will touch quality and regulatory professionals this year, longtime industry insider Steve Niedelman says in this Medtech Insight podcast. Other topics to watch: FDA’s recent string of new guidances; the 21st Century Cures Act.

2017

Open Media

Boston, Florida and Los Angeles will likely be home to new FDA divisions dedicated to coordinating inspections of device manufacturers under the agency’s in-the-works “program alignment” inspection initiative, a longtime...

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Pathogen Sharing System Part Of Global Pandemic Agreement

 
• By Neena Brizmohun

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FDA Halts Acceptance Of Chinese Lab Data Due To Accuracy Issues

 
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• By Ashley Yeo

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