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Expanded Access Guidance On COVID-19 Will Inform US FDA’s Post-Pandemic Policies

 
• By Sue Sutter

In line with Commissioner Hahn’s view that lessons learned during the pandemic will have a lasting impact on FDA policies and procedures, new guidance on IRB review for individual patient access requests will be revised after the public health emergency ends to reflect agency’s implementation experience.

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US FDA is giving advice to IRBs on how to handle individual patient expanded access requests. • Source: Shutterstock

A new guidance on individual patient expanded access requests for investigational COVID-19 treatments appears to reflect US Food and Drug Administration commissioner Stephen Hahn’s view that some agency processes and policies adopted during the novel coronavirus outbreak should outlast the public health emergency.

Released on 2 June, the guidance provides recommendations on key factors and procedures that institutional review boards should consider...

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