This guidance provides FDA’s current thinking on the scope and application of 3-year exclusivity under section 505(c)(3)(E)(iii) and 505(j)(5)(F)(iii) of the FD&C Act for drug products approved with new clinical investigations (other than bioavailability studies) essential to approval.
The Q&A format clarifies regulatory expectations for sponsors seeking exclusivity based on new clinical data
This guidance is particularly important for sponsors developing supplements, reformulations, or new indications, as strategic clinical development planning can significantly impact market protection timelines.