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CBER’s ‘Courageous’ Coronavirus Guidance Strategy May Catch-On

 
• By Derrick Gingery

Director Peter Marks says faster guidance development practices produced well-written documents and may be adopted once the pandemic ends.

GUIDANCE CONCEPT
CBER staff realized that writing guidance faster does not mean the recommendations will be lower quality , Director Peter Marks said. • Source: Shutterstock

Some of the better guidances to come out of the US Food and Drug Administration’s Center for Biologics Evaluation and Research recently were written under coronavirus-related pressure, and director Peter Marks said the lessons could lead to permanent process changes once the pandemic is over.

Among the efficiencies required for the pandemic response has been a much more truncated timeline for some guidance documents. Marks...

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