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FDA Finalizes Guidance Documents Aimed At Easing Post-Pandemic Regulatory Transitions

 
• By Elizabeth Orr

The documents describe the US agency’s preferred approach toward products cleared under EUAs or other alternate approaches during the COVID-19 public health emergency.

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The US Food and Drug Administration eased up on labeling recommendations but kept a controversial 180-day compliance period in two newly finalized guidance documents aimed at easing the transition out of the COVID-19 public health emergency (PHE), which is set to end in May.

The documents recommend strategies for developing a transition implementation plan, completing a marketing submission, and other key tasks. One applies to products that have been marketed under emergency use...

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