1. Pink Sheet

PDUFA VII Talks To Begin With COVID-19, Other Familiar Issues To Consider

 
• By Derrick Gingery

US FDA staffing problems and patient engagement enhancements will be listed as priorities during reauthorization kick-off meeting.

Building icon with inscription FDA and flag of The United States over abstract background. - Illustration
Real-world evidence and complex clinical trial issues also likely will emerge during the public meeting as PDUFA VII negotiation topics. • Source: Shutterstock

After years of planning, the most impactful changes for the US Food and Drug Administration through the renewal of the prescription drug user fee program may originate in lessons from something that caught many by surprise – the coronavirus pandemic.

Stakeholders will meet on 23 July to formally begin the sixth PDUFA reauthorization process, which will set the course of...

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