1. Medtech Insight
  2. >>Policy & Regulation

FDA Reorganization Advocates Seek Senate Boost For Disease-Oriented Structure

Friends of Cancer Research proposes realignment of FDA to be organized more around disease areas and less around the distinctions between drugs, devices and biologics. The idea has generated some support from former commissioners and current officials, while others warn of unintended consequences.

A proposal to reorganize FDA's centers from a product-based structure to one oriented by therapeutic area could gain more traction with the Senate's forthcoming draft of its medical innovation legislation.

A Friends of Cancer Research (FOCR) proposal to realign FDA according to disease area is drawing mixed reviews from current...

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 Regulation

More from Policy & Regulation

FDA Panel Supports Dermal Fillers For Décolletage Use

 
• By Elizabeth Orr

An FDA panel has endorsed the use of dermal fillers for décolletage, but warned of patient safety concerns. The filler can cause complications with future imaging and pregnancy or breastfeeding, panelists said. Regulatory measures and patient studies are recommended for better outcomes.

NAD Alerts Agendia Over Endorsing Physician’s Ties To Firm

 
• By Elizabeth Orr

The National Advertising Division (NAD) alerted Agendia to improve disclosure regarding a physician endorsing its MammaPrint test. The physician's ties to Agendia were inadequately revealed in LinkedIn posts.

FDA Ends Effort To Regulate LDTs By Rescinding Final Rule

 
• By Brian Bossetta

Just a year and four months after publishing a final rule that would have allowed it to regulate laboratory developed tests as medical devices, the US FDA has rescinded the controversial measure, finally putting an end to the saga.