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Speaking Of Medtech, Ep. 5: MDUFA V User-Fee Negotiations

 
• By Steve Silverman and Shawn M. Schmitt

In this episode of Speaking Of Medtech we discuss the Medical Device User Fee Amendments, or MDUFA, the negotiations for which come around every five years. The MDUFA V talks between industry and the US FDA appear with the inevitability of an unloved season – it seems no one is ever terribly excited to engage in the user-fee process. Here, we break things down.

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More from Regulation

FDA Scrubs ‘Gender’ From Final Guidance On Sex-Specific Data But Encourages More Women In Clinical Trials

 
• By Brian Bossetta

The US FDA has published its final document to guide sponsors on using sex-specific data in designing clinical trials of medical devices. However, the guidance removes all references to gender that appeared in January’s draft guidance, released before the Trump administration took office.

HHS Has ‘Utterly Failed,’ Kennedy Advisor Argues

 
• By Cathy Kelly

Calley Means defended reductions in force at the Health and Human Services Department that shocked and outraged federal workers and stakeholders.

Regulatory Experts Alarmed By Credible April Fool’s About US Targeting EU Notified Bodies

 
• By Amanda Maxwell

A seemingly humorous social media post on April Fool’s Day struck a nerve with regulatory experts, reflecting real concerns about recent actions by the US Food and Drug Administration.

US Could Lose Its First Approver Advantage After FDA Layoffs

 
• By Sarah Karlin-Smith, Elizabeth Orr, and Derrick Gingery

Mass FDA layoffs on 1 April were designed to spare product reviewers, but still touched many who are critical to the application review process or drug development, which could mean fewer treatments are brought to the US market first.

More from Policy & Regulation

HHS Has ‘Utterly Failed,’ Kennedy Advisor Argues

 
• By Cathy Kelly

Calley Means defended reductions in force at the Health and Human Services Department that shocked and outraged federal workers and stakeholders.

Some Staff Say Makary’s First Speech To FDA Off-Target Despite Science Focus

 
• By Derrick Gingery, Sarah Karlin-Smith, and Sue Sutter

Some employees were not impressed with FDA Commissioner Martin Makary's first speech to the agency staff, saying he did not seem to understand the agency's mission.

Swiss Blast US Import Tariffs As Medtechs Look For Dialog To Forestall Damage To Industry

 
• By Ashley Yeo

Swiss medtech exporters seek urgent diplomatic action from the Swiss Federal Council in a bid to overturn the 2 April US decision to put tariffs on goods imports.