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2021 Forecast Includes Rise In FDA Enforcement Actions

 
• By Elizabeth Orr

The Biden administration may take a heavier hand with manufacturers than we saw in recent years, attorneys say.

Continuing fallout from the COVID-19 pandemic, user-fee negotiations and potential legislative action are among the device regulatory areas two attorneys from the law firm Paul Hastings expect to be paying close attention to during the coming year.

During a 28 January webinar, the attorneys said to watch any moves on remote inspections from the US Food and Drug Administration. The agency has been reluctant to conduct them as compared to other regulatory bodies, but seems to be slowly getting on board – a move Paul Hastings partner Peter Lindsay says may cause new concerns. For example, FDA regulators with specific expertise in a product area may pop into a virtual inspection even if they aren’t officially part of the inspection team

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