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BIO 2021 Notebook: Looking Past The Pandemic

Annual Meeting Focuses On Post-COVID R&D, Politics And New Opportunities

 
• By Scrip Team and Pink Sheet Team

News and views from day one of the BIO Digital annual meeting include debate about when FDA will go back to the offices, industry's role in pandemic-related policy discussions and how to prepare for the next pandemic. 

BIO 2021 Notebook - Day 1

The COVID-19 pandemic changed the conversation about the biopharma industry from pricing, reimbursement and affordability to “how could we save the world,” Cerevel Therapeutics Holdings, Inc. CEO Tony Coles said during a 14 June fireside chat on the opening day of the Biotechnology Innovation Organization annual meeting.

Now, with society largely grateful and appreciative of the industry’s speedy work and innovation in delivering products for COVID-19, the...

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More from US FDA

US FDA To Advisory Committee Industry Reps: Don’t Talk Too Much

 
• By Sue Sutter

Nonvoting industry representative’s presence at Pediatric Advisory Committee meeting was required by statute, the agency said, a de facto acknowledgement that an April directive precluding industry reps from sitting on advisory committees has had little practical effect.

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• By Sarah Karlin-Smith

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• By Derrick Gingery

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

 
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More from Agency Leadership

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

 
• By Derrick Gingery

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

 
• By Michael McCaughan

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

 
• By Sue Sutter

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.