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US FDA’s ‘Platform’ Pathway Fits For LNPs And siRNA But Not Delivery Devices

 
• By Michael McCaughan

The US FDA’s new guidance defining a “Platform Technology Designation” makes clear that what counts as a “platform” may not match industry’s use of the term.

diving platform
Monoclonal antibody platforms also are among the technologies that could receive a platform designation from the FDA. • Source: Shutterstock

The idea of a biotech “platform” company is almost as old as the biotech sector itself.

Key Takeaways

  • Sponsors may find that their definition of platform technology is different from the FDA’s thinking.

  • Lipid nanoparticle platforms are among the technologies that could qualify for the designation

The pioneering biotech company Genentech, Inc. is arguably the first example

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