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US FDA 2020 Budget Request Is Parting Gift From Commissioner Gottlieb

 
• By Michael McCaughan

The Trump Administration’s request to increase FDA funding by 12% is a reminder of the behind-the-scenes benefits brought to FDA by the outgoing commissioner. The proposed increase for FDA stands in stark contrast to what is otherwise an austerity budget for HHS agencies.

Budget 2020. The inscription on the missing element of the puzzle. Folded white puzzles elements and one red with word BUDGET 2020. 3D Illustration - Illustration

US FDA Commissioner Scott Gottlieb is giving his successor a very nice parting gift in the form of a large requested funding increase in the Trump Administration’s latest budget proposal.

President Trump’s fiscal 2020 budget request seeks a 12% increase in appropriated funding for the Food & Drug Administration in...

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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.

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• 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.