Does US FDA Need An Independent Commission To Analyze Its Pandemic Response?
Group of outside experts could help the agency determine the pandemic-inspired practices and regulatory changes to keep, former commissioner von Eschenbach says.
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Next-Gen Vaccine Makers Want Up-Front Discussions With US FDA To Expedite Development
Early conversations on clinical trial endpoints were particularly helpful in developing Comirnaty, a Pfizer executive said. Whether sponsors can continue to get such discussions may go a long way in determining whether a new generation of products is developed.
Outgoing Merck CEO Touts COVID Innovations, But Worries Pandemic Prep May Lack Staying Power
Ken Frazier says advocates need to ensure governments continue investing in global biosecurity.
Pondering The Future Of In-Person Meetings At The US FDA
Stakeholders believe virtual meetings should remain an option going forward, but that in-person sessions should still be convened in many cases.