FDA To Add Ophthalmic And Orthopedic Devices To TAP Pilot

The program, which brings together innovators and device industry stakeholders, helps ease the path to market for novel devices. 

The US Food and Drug Administration plans to add two more product areas to its ongoing Total Product Life Cycle Advisory Program (TAP), the agency announced on 1 July.

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

 

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 However, the guidance removes all references to gender that appeared in January’s draft guidance, released before the Trump administration took office.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

 
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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

 

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

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.

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