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Supplemental Filings: Back To US FDA’s Conference Center, What Marks Wants In A Gene Therapy Director, And More

 
• By Pink Sheet Team

Short stories about how US FDA’s conference center changed since COVID-19 forced the end of in-person public events, what the agency did to officially close the books on Makena, and more.

GDUFA regulatory science priorities meeting
The FY 2023 generic drug regulatory science priorities meeting at the US FDA seemed familiar. • Source: Derrick Gingery

Welcome to another edition of Supplemental Filings, where US-based Pink Sheet reporters offer bonus, quick-hit analysis and insights we think you should know about, but didn’t make it into full-length stories.

The COVID-19 pandemic may have forced a lot of changes in society, but the US Food and Drug Administration’s conference...

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More from US FDA

Last Minute Course Shifts, Focus On Unknowns: What Sponsors Should Learn From Prasad’s Interventions

 
• By Sarah Karlin-Smith

The once and current CBER director’s justification for his COVID-19 decision stands as a warning of the uncertainty sponsors, particularly those in the vaccine space, may now face at FDA.

Precigen’s Papzimeous Approval Allows US FDA CBER Director To Emphasize Flexibility

 
• By Bridget Silverman

Returning FDA biologics center director Vinay Prasad used the Papzimeous approval announcement to reinforce his flexibility on rare disease therapies after several complete response letters and his brief departure from the agency.

A US FDA Move to Revoke Pfizer’s Pediatric COVID-19 Vaccine EUA Could Raise Supply Questions

 
• By Sarah Karlin-Smith

Pfizer still has not submitted a supplemental biologics license application for the youngest population even though people familiar say it has dominated that market. Moderna says it can “step up” supply.

Prasad’s Return Shelves Center Consolidation, But Maybe An Opening For OCE 2.0?

 
• By Kate Rawson

Vinay Prasad’s exit from the US FDA reignited conversations about integrating its drugs and biologics centers under George Tidmarsh. Those plans appear to be shelved, but the leadership transition could be an opportunity to fully realize the vision for the Oncology Center of Excellence.

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