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US FDA Commissioner Nominee On Fast Track With Nov. 20 Hearing

 
• By Nielsen Hobbs

Stephen Hahn will go before the Senate health committee less than three weeks after being nominated. Pink Sheet's historical charts illustrate how a long wait and a quick hearing could mean a rapid confirmation.

Senate health committee chairman Lamar Alexander, R-TN, meets with US FDA commissioner nominee Stephen Hahn. • Source: office of Sen. Lamar Alexander

Stephen Hahn's nomination to lead the US Food and Drug Administration was a long time coming, but it appears that Senate leadership is hoping that his time as nominee will be pleasantly short, with a hearing in the Health Committee now scheduled for 20 November.

Sen. Lamar Alexander, R-TN, announced on 6 November that he was supporting the nomination.

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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.

EMA Revives Face-To-Face Oral Explanations In Response To Industry Feedback

 
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The European Medicines Agency is bringing back in-person oral explanation meetings with drug sponsors on a pilot basis, following industry feedback that direct engagement with its scientific committees is highly valued.

Prasad 2.0 Brings New Instability Concerns, Questions About Changed Regulatory Philosophy

 
• By Sarah Karlin-Smith

Many agency stakeholders believe Vinay Prasad may be forced to change his regulatory approach at least somewhat after receiving a second chance to lead the US FDA's biologics center.

More Telework, More Staff, US FDA’s Tidmarsh Plans To Alleviate Workforce Challenges

 
• By Sarah Karlin-Smith

The new CDER director focused on plans to improve morale during an Aug. 8 townhall, but staff comments indicate that may be a challenge.

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New EU Filings

 
• By Neena Brizmohun

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With Thyroid Petition Win, AbbVie Snares Itself; US FDA Sets Up Another Compounding Fight

 
• By Manas Mishra

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Could Study Questioning GLP-1 Cost Savings Impact CMMI Demo Chances?

 
• By Cathy Kelly

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