The 505(b)(2) NDA pathway is increasingly utilized to bring improved and differentiated products to market faster and more cost effectively. 505(b)(2) products often utilize enabling technologies to create better medicines through new formulations, new dosage forms, and new combinations which can result in up to 7 years of market exclusivity dependent. Join Camargo and Capsugel in discussing 505(b)(2) challenges, recent regulatory updates, and case studies demonstrating successful application of enabling technologies in 505(b)(2) product development.
Ken V. Phelps
President & CEO
Camargo Pharmaceutical Services
Director, Product Development
Capsugel Dosage Form Solutions