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Public Health Groups Doubt FDA’s ACNU Proposal Will Expand OTC Access, Benefit Public Health

Public Citizen, National Center for Health Research, American Heart Association Have Concerns

 
• By Malcolm Spicer

Agency has comments from Public Citizen, National Center for Health Research and American Heart Association to consider among 182 submitted on proposed published in June. FDA set a non-binding target date of October to publish “Nonprescription Drug Product With an Additional Condition for Nonprescription Use” final rule.

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Expanding access to nonprescription drugs and improving public health aren’t likely to result from a US Food and Drug Administration proposed rule targeting those and other goals, say Sidney Wolfe and other public health advocates.

The agency has comments from Wolfe and others submitted in November to consider among the 182 submitted to the docket...

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New US FDA CDER Director Pledges No Politics In Approvals, Adds Higher Ups Can Overturn

 
• By Sarah Karlin-Smith

New CDER Director George Tidmarsh promised to keep politics out of drug approvals, but suggested during a meeting with staff that he could not insulate the drug center from political pressures coming from those above him.

New US FDA Chief Counsel More Familiar With Trump World Than Food and Drug Law

 
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Manufacturers Can Keep Their Shoes On: FDA PreCheck To Streamline US Facility Applications

 
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NDA User Fees Increasing 8.6% As FDA Projects More Applications But Fewer Sponsor Meetings

 
• By Nielsen Hobbs and Derrick Gingery

The ups – and some downs – of the US FDA’s prescription, biosimilar, and generic user fees for FY 2026 are tabulated by the Pink Sheet.

More from Policy & Regulation

New US FDA Chief Counsel More Familiar With Trump World Than Food and Drug Law

 
• By Sarah Karlin-Smith

Sean Keveney is largely unknown in the FDA law space, but likely is familiar and connected to the White House given his work on Trump’s antisemitism taskforce.

Industry Pleased To See Self-Care In Revised English Children’s Education Policy

 
• By David Ridley

Children and young adults will in future learn more about responsible self-care, including when it is appropriate to see a pharmacist, specific instructions for dental health and information about health risks associated with smoking, vaping, and other nicotine products such as nicotine pouches.

Manufacturers Can Keep Their Shoes On: FDA PreCheck To Streamline US Facility Applications

 
• By Derrick Gingery

The program would allow early interactions with FDA staff to speed construction and approval of pharmaceutical manufacturing facilities in the US, but will staff be available?