1. Pink Sheet
  2. >>Agency Leadership
  3. >>US FDA

‘Intended Use’ Rule: Industry Urges US FDA To Revoke ‘Totality Of Evidence’ Standard

 
• By Brenda Sandburg

Trade groups say final rule would allow any activity to be considered evidence of a manufacturer’s intended use of a product and increase exposure to potential liability.

FDABldg1ExteriorWithCircle_1200x675

A final rule FDA issued in January has shaken industry groups who say it creates a new legal standard for assessing a manufacturer’s “intended use” of a product that will allow any evidence to be used to bring a criminal misbranding action – thus exposing companies to potential liability for normal business activity.

Revisions to the “intended uses” regulations were included in a final rule on tobacco-derived products. “If the totality of evidence...

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on Pink Sheet 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 US FDA

Pink Sheet Podcast: Prasad Staying Out Of Application Reviews, US FDA Proposed Budget Cuts

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

Pink Sheet reporter and editors discuss CBER Director Vinay Prasad’s expectation to stay out of routine application decisions, despite the agency’s top-down leadership approach, and the extent of proposed FDA budget cuts.

To Compete With China, US FDA Must Deregulate Early Gene Therapy Studies, CAR-T Inventor Says

 
• By Sarah Karlin-Smith

FDA regulation was painted as an obstacle to US dominance in the cell and gene therapy space even as panelists at an agency event praised the Office of Therapeutic Products' track record under Nicole Verdun.

Prasad Says Involvement In US FDA Product Approvals Will Mirror Prior CBER Directors

 
• By Sarah Karlin-Smith

The remarks from the new CBER director suggest Prasad will not be involved in most product-specific decisions.

US FDA Cell-Gene Therapy Head Says Agency Has Revived Stalled Programs

 
• By Sarah Karlin-Smith

CBER's Nicole Verdun wants rare disease sponsors with stalled treatments to circle back because the FDA's evolved thinking on clinical trial designs may offer another opportunity for cast away products.

More from Agency Leadership

Delese Mimi Darko Appointed To Lead African Medicines Agency

 
• By Anabel Costa-Ferreira

Darko has become the first director-general of the AMA, an organization set up to transform access to quality-assured medicines across Africa and foster a more predictable, efficient regulatory environment for innovation.

Prasad Says Involvement In US FDA Product Approvals Will Mirror Prior CBER Directors

 
• By Sarah Karlin-Smith

The remarks from the new CBER director suggest Prasad will not be involved in most product-specific decisions.

US FDA Cell-Gene Therapy Head Says Agency Has Revived Stalled Programs

 
• By Sarah Karlin-Smith

CBER's Nicole Verdun wants rare disease sponsors with stalled treatments to circle back because the FDA's evolved thinking on clinical trial designs may offer another opportunity for cast away products.