FDA Plans To Improve COVID-19 EUA Process, Inspection Work Based On Report Recommendation

The agency is taking to heart several recommendations made by an independent reviewer earlier this year in a report on its COVID-19 response.

Sign outside of FDA's headquarters in White Oak, MD

An independent report on the US Food and Drug Administration’s COVID-19 response is spurring the agency to make some changes intended to improve how it handles emergency use authorization applications and communicates with industry.

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LDT Saga Comes To A Grinding Halt As Judge Sides With Labs, Vacates FDA’s Final Rule

 

A federal judge in Texas delivered what is most likely a fatal blow to the US FDA’s final rule, which would have regulated lab-developed tests as medical devices.

How Cutting Edge Technology Is Changing Risk Management In the EU

 

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