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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New draft guidance defines the necessary components of a platform technology designation request, including that sponsors demonstrate how it will save the FDA review time.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should justify how the technology is reasonably likely to make the application review more efficient, a new agency draft guidance says.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.”

  • Sponsors must show their technology will allow for a faster FDA review, but will not get an earlier user fee date

The guidance, released 28 May, seems to emphasize the requirement that a platform technology is likely to bring significant efficiencies to the review compared to other statutorily demanded criteria

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