US FDA Commissioner Transition: Sharpless Audition Is Ending – Will He Get The Part?

Ned Sharpless has been acting head of the US FDA for five months but has not yet been formally nominated for the permanent post. The emergence of another new name as a possible candidate underscores how uncertain the transition still is.

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It has been six months since Scott Gottlieb announced that he would be resigning as commissioner of the US Food & Drug Administration, and there is still no formal nominee to succeed him.

That is likely to change soon: under federal law governing vacancies for Senate confirmed positions, an agency can only be...

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Learn what's happening at the US FDA. On the go.

Derrick Gingery and the team bring you a weekly "Drug Fix".

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PS-AgencyLeadership (Premium-1): Study Reveals How Immune System of Astronauts Breaks Down

Recent studies show that spaceflight can significantly weaken astronauts’ immune systems, making them more susceptible to infections and health complications during and after missions. Understanding these changes is crucial for ensuring the safety of future long-duration space travelers.

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New US FDA Adcomm Trend: Approved Cancer Meds Get Another Look When Competitors Coming

 

Recent ODAC meetings suggest the FDA will expand focus beyond applications with pending approval decisions to refining trial designs and drug labels for competitors.

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The US FDA Commissioner pushed for a rebalancing of the US’s pharmaceutical supply chains while also stressing that there is a role for US-China commerce that would be risky to compromise.

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New US FDA Adcomm Trend: Approved Cancer Meds Get Another Look When Competitors Coming

 

Recent ODAC meetings suggest the FDA will expand focus beyond applications with pending approval decisions to refining trial designs and drug labels for competitors.

Califf: Not Wise To Create Problems Related to Chinese Pharma Supply Chain Dependence

 

The US FDA Commissioner pushed for a rebalancing of the US’s pharmaceutical supply chains while also stressing that there is a role for US-China commerce that would be risky to compromise.