Coronavirus Notebook: US FDA's Paper Push, Industry Execs/US Officials Emphasize Their Collaboration

Dispatches from a world turned upside down include the US FDA expressing confidence in Chinese manufacturers – to make their GDUFA payments; projections of drug shortages for ventilator patients; and the launch of new hydroxychloroquine studies.

Coronavirus map

As the completely abnormal starts to feel routine, the Pink Sheet offers periodic dispatches about how the coronavirus pandemic is changing the operations of sponsors and regulators. Here are some recent stories from the United States.

Pharma executives and other stakeholders had a call with US Food and Drug Administration Commissioner Stephen Hahn twice in five...

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US FDA Staff Stability Should Be A Congressional Priority, Former Chief Of Staff Says

 

Lawmakers should address FDA staff upheaval and help the agency “get back on track,” former agency Chief of Staff Elizabeth Jungman said, while CBER Director Vinay Prasad told staff he is asking ex-colleagues to return to the agency.

US FDA ‘Commissioner’s Voucher’ As Public Relations Tool

 

NRx Pharma is trying to capitalize on the headlines about a new US FDA hyper-fast review program, illustrating that the lack of details in the FDA’s announcement is an opening for sponsors to try to grab some attention.

HHS Wants Employees (And Public?) To Report Diversity, Equity And Inclusion Discrimination

 
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A survey asks FDA staff to disclose whether DEI policies caused discrimination or resulted in disciplinary action against career employees over the past five years, but uses a web form that the general public also can access.

Kennedy Appears Ill-Informed On Major Pharma Priorities, Creating Unique Lobbying Dynamics

 

The Health and Human Services Secretary made incorrect statements about the status of key industry priorities at a recent House hearing, which actually may be a good thing for drug sponsors.

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