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The Evolving Door? What Having A ‘Big Data’ Commissioner Might Mean For US FDA

 
• By Cole Werble

Robert Califf’s nomination to return as FDA commissioner will raise protests about a ‘revolving door’ pathway between industry and agency. But, in this case, it may be more apt to talk about how Califf’s time outside FDA led to evolving views on the role of big data in drug regulation.

US FDA entrance
FDA Building 1 actually uses dual sliding doors, which are good for climate control and emergency egress, but perhaps not as effective when it comes to metaphors. • Source: Alamy

The selection of Robert Califf as the new head of the US Food & Drug Administration (subject to Senate approval) begs for criticism about the so-called “revolving door” between government agencies and the industries they regulate.

President Biden’s nomination of Califf to return to FDA is getting its share of those complaints, led by Public Citizen,...

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US FDA Could Miss User Fee Spending Triggers With House FY 2026 Funding

 
• By Sarah Karlin-Smith and Derrick Gingery

FDA employees are concerned that while the budget authority total proposed for fiscal year 2026 meets the user free appropriations' triggers, the FDA could have trouble meeting allocation triggers without cuts to non-review work.

US FDA May Consolidate Support Services After Extensive Cuts

 
• By Derrick Gingery and Sue Sutter

Commissioner Martin Makary told staff that plans are being developed to centralize HR, IT, travel and other functions, which were heavily impacted by the 1 April reduction-in-force.

US FDA’s Rising First-Cycle Complete Response Rate Draws Congress’ Attention

 
• By Sue Sutter

The House Appropriations Committee wants an analysis of how issues that led to CRLs could have been resolved within the first review cycle and seeks an agency crackdown on counterfeit GLP-1 agonists.

ACIP Upheaval Leaves Merck & Co. In A Lurch

 
• By Jessica Merrill and Bridget Silverman

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US FDA Chief Counsel Position Awaits HHS General Counsel Confirmation

 
• By Sue Sutter

Robert Foster, HHS deputy general counsel and chief counsel for food, research and drugs, is temporarily heading the Office of Chief Counsel, but a permanent appointee is expected after Michael Stuart's confirmation as HHS general counsel.

HHS Secretary Favors Regenerative Medicine Over Traditional Pharma: Blessing And Curse?

 
• By Sarah Karlin-Smith

Cell and gene therapy developers may not have to contend with HHS Secretary Robert F. Kennedy Jr.’s animosity like the traditional pharma industry, but his disinterest in distinguishing between the good and bad actors in the space could backfire.

Generic Drug Office’s Policy Staff Returning To US FDA

 
• By Derrick Gingery

The group had been laid off as part of the 1 April reduction-in-force, which led to missed guidance publication deadlines.