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New draft guidance defines the necessary components of a platform technology designation request, including that sponsors demonstrate how it will save the FDA review time.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

More from Platform Technologies

More from Advanced Technologies