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US FDA Is Developing Guidance For Interactive Video GMP Evaluations During COVID-19

 
• By Bowman Cox

While agency prepares guidance, official advises manufacturers to prepare live streaming video systems if they want to host such inspection alternatives.

IT Engineer Wearing Virtual Reality Headset Works with Augmented Reality Software in Data Center. He Wirelessly Interacts with Rack Servers by Icon Visualisation.
coming soon: how fda will evaluate sites virtually • Source: Shutterstock

In the clearest sign yet of the US Food and Drug Administration’s growing acceptance of so-called virtual drug good manufacturing practice inspections during the coronavirus pandemic, an FDA official said 2 November that the agency is developing industry guidance on the topic.

The FDA has lagged behind other regulatory authorities including the European Medicines Agency and the UK Medicines and Healthcare products Regulatory Agency in adopting remote video virtual inspection approaches. (Also...

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