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

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.

The pioneering biotech company Genentech, Inc. is arguably the first example. It owned the fundamental patent on recombinant...

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