1. Medtech Insight

Draft FDA Reorganization Would Unite All Product Centers

 
• By Sarah Karlin-Smith

Product reviews for drugs, biologics, devices, tobacco and foods could be consolidated into one office at the FDA, as part of a restructuring plan circulating that was obtained by Pink Sheet.

Puzzle pieces being brought together. Concept: Merger, unity.
(Summit Art Creations/Shutterstock)

All of the US Food and Drug Administration’s product review and regulatory decision-making across drugs, biologics, devices, tobacco and foods would be consolidated into one office under a reorganization plan circulating among agency staff and obtained by Medtech Insight sister publication the Pink Sheet.

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on Medtech Insight for daily insights

  • Start your 7-day free trial
  • Explore trusted news, analysis, and insights
  • Access comprehensive global coverage
  • Enjoy instant access – no credit card required
Start Free Trial

Already a subscriber?

More from Medtech Insight

Biolinq’s $100M In Series C Financing Supports Efforts To Bring Diabetic Glucose Monitoring With Needle-Free Patch To Market

 
• By Marion Webb

Biolinq plans to use the proceeds of its new venture funding to support US FDA de novo review, automation engineering and commercialization efforts with partners, CEO Rich Yang told Medtech Insight.

Migraine Relief Without A Pill: Click’s FDA Cleared CT-132 Turns Smartphone Into Therapy Tool

 
• By Shubham Singh

Built on Click’s AI-enabled platform, CT-132 delivers a 12-week behavioral intervention program rooted in multiple evidence-based techniques, including cognitive behavioral therapy (CBT) and bio-behavioral approaches. The goal: reduce brain hypersensitivity and enhance patients’ resilience to migraine triggers.

OneCell Diagnostics – Now 1Cell.Ai - Launches Multi-Modal Cancer Diagnostic Panel OncoIncytes

 
• By Natasha Barrow

OneCell Diagnostics, the Mumbai-based startup backed with $16m in series A funding, is rebranding to 1Cell.Ai to represent the firm's focus on combining deep science with AI-powered capabilities.

Update: Italy’s IMQ And Belgium’s SGS Named 15th and 16th IVDR Notified Bodies

 
• By Amanda Maxwell

Ireland’s NSAI reinstated under IVD Regulation designation list

More from Regulation

Keeping Germany’s Medtech Industry Apprised, Advised and Incentivized in Turbulent Times

 
• By Ashley Yeo

A change of government, hospital reform and a drive towards healthcare digitization are keeping German medtech manufacturers on their toes. Making the MDR more user-friendly and winning support for a medtech strategy are arguably bigger priorities. US export tariffs have also pushed their way onto the agenda. BVMed chief executive Marc-Pierre Möll puts it all into context.

Secretary Kennedy’s FDA Visit Included CDRH Stop, Speech Warning Of ‘Agency Capture’

 
• By Sue Sutter

HHS Secretary Robert F. Kennedy Jr. urged FDA staff to resist the “deep state” and “crony capitalism,” and focus on improving the health of America’s children. “You're not here to take orders,” he said and urged FDA staff to speak up if they see wrongdoing.

FDA Reverses Course, Allows Some Telework For Reviewers

 
• By Derrick Gingery

The new telework policy returns to the pre-COVID-19 pandemic standard, but still requires reviewers to be at White Oak for sponsor meetings and divisions to have an in-office presence every day.