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Platform Tech Designation: US FDA Emphasizes “Significant Efficiencies” Criteria In New Guidance

 
• By Sarah Karlin-Smith

New draft guidance defines the necessary components of a platform technology designation request, including that sponsors demonstrate how it will save the FDA review time.

Hand is replacing part of a DNA molecule
Gene therapy is one area where the platform technology designation likely will be useful. • Source: Shutterstock

Sponsors seeking a platform technology designation from the US Food and Drug Administration should justify how the technology is reasonably likely to make the application review more efficient, a new agency draft guidance says.

Key Takeaways

  • The new platform technology designation program will require the FDA and industry to get comfortable with new terms, including for “platform technology.”

The guidance, released 28 May, seems to emphasize the requirement that a platform technology is likely to bring significant efficiencies...

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