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COVID 19

Coronavirus Prompting Reaction in Washington

February 10, 2020

The newest mutation to the coronavirus has had a massive impact in China and has prompted a reaction from the World Health Organization (WHO). The impact on makers of devices and diagnostics has...

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FDA, Draft Guidance, Regulatory and Compliance

FDA Inks Combo Product Feedback Guidance

January 29, 2020

The FDA and industry have been at loggerheads over various issues surrounding combination products, but a new draft guidance may help resolve some of those conflicts. The draft deals with...

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