Skip to content
Articles

(b)(2) or not to be, that is the question

USFDA 505(b)(2) pathway submissions (“(b)(2)s”) can be advantageous because they offer the potential for the accelerated approval of patient-centric medicines. Dr. Jamie Unwin, Commercial Insight Officer at Nanoform, sat down with Timothy Pang, Executive Director, Pharma Consulting at Informa Pharma Custom Intelligence to discuss the current industry landscape with regards to (b)(2)s, and to reflect through some unique performance insights how patient-centric drug development has generated commercial value in recent times. Further, they discussed their view on the future direction of the industry with regards to the adoption of (b)(2) approaches, and the key technological advances that can empower these.