Industry calls on FDA to clarify, expand platform tech program
Comments on the agency’s guidance document include requests that it extend the designation to platforms that have yet to yield an approved drug
FDA’s platform technology program could be as important for drug developers as accelerated approval — if the agency interprets its authority broadly and implements the program effectively. The biopharma industry is eager to make the pathway work and has leaned into FDA’s invitation to comment on draft guidance.
FDA’s guidance document Platform Technology Designation Program for Drug Development was the first step in creating a predictable pathway for drug manufacturers to leverage and reuse technologies for multiple products. Allowing manufacturers and regulators to focus on what is different about a new medicine, rather than generating and reviewing data that are uninformative, can accelerate product development and improve the quality of reviews...