1. Pink Sheet
  2. >>Advanced Technologies

US FDA Not Ready For Sponsors Citing Others’ Platforms Yet, Marks Says

 
• By Derrick Gingery

Many platform designation requests have been from sponsors eager to cite other sponsors’ products, but CBER Director Peter Marks said in an interview with the Pink Sheet his office likely is years away from accepting those applications.

subway platform, mind the gap
A gap in platform designation program expectations has emerged between sponsors and the FDA. • Source: Shutterstock

Industry may be eager to use rival sponsor technology as a platform for additional approvals, but the US Food and Drug Administration is not.

Key Takeaways

  • CBER has not awarded any platform designations yet.

  • Many requests have asked the FDA to reference products from another sponsor as a platform

The platform designation program is intended to streamline development of products that use a similar backbone, but change some components to treat multiple diseases

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 Platform Technologies

More from Advanced Technologies