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US FDA Provides Monkeypox Update, Including Testing Protocols

 
• By Brian Bossetta

The Centers for Disease Control and Prevention (CDC) is providing the non-variola orthopoxvirus test throughout its public health Laboratory Response Network. The diagnostic is currently the only FDA-cleared test to detect monkeypox.

MONKEYPOX Concept
• Source: Shutterstock

As if one global pandemic wasn’t enough, another one seems to be rising in its wake.

Since May, the World Health Organization (WHO) has declared a global health emergency over the outbreak of the monkeypox virus, which has spread across multiple countries, including the US.

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• By Brian Bossetta

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More from Policy & Regulation

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.

UK Take Care! Regulatory And Market Access Reforms Must Not Shut Out Medtech Growth

 
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