Product Development Using the NDA 505(b)(2) Approval Pathway

The 505(b)(2) NDA pathway is increasingly used to bring improved and differentiated products to market faster and more cost effectively. 505(b)(2) products often use 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. This webinar describes 505(b)(2) challenges, recent regulatory updates, and case studies demonstrating successful application of enabling technologies in 505(b)(2) product development.