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FDA Updated Its eMDR System. Here’s What You Need To Know When Submitting Adverse Events

 
• By Shawn M. Schmitt

The US agency has completed planned modifications to its electronic Medical Device Reporting system – and added an extra field for MDR exemption numbers.

Update

The US Food and Drug Administration has completed a scheduled update of its electronic Medical Device Reporting (eMDR) system.

The agency had announced in June that it would make modifications to the system by September. ([A#MT142233])

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Under Pressure: How To Safeguard The EU Responsible Person

 
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Number of Persons Responsible For Regulatory Compliance Grows Nearly 10%

 
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Italy’s Responsible Person Sanctions Approach Raises Eyebrows

 
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A Trillion On The Table. Addressing Disparities In Women’s Health Isn’t Just Right. It’s Smart.

 
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Italy’s Responsible Person Sanctions Approach Raises Eyebrows

 
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