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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.

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

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