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US FDA's Regulatory Pipeline Includes DTC, Inspection Requirement Updates

 
• By Derrick Gingery

Additionally, potential regulation to require clinical study sponsors to promptly report suspected data falsification seems to have found new life after being listed as inactive in July update of the Unified Agenda.

FDA entrance sign 2016

The US FDA intends to revoke or revise some regulations in the coming years in addition to potentially complete work on some well-known issues in the drug space.

The latest update of the Unified Agenda, the White House Office of Management and Budget's list of planned proposed and...

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More from US FDA

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

Merck’s newly approved Enflonsia for RSV is one of the products expected to be recommended for use by the CDC Advisory Committee on Immunization Practices later this month.

More from Agency Leadership

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.